• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) HYLAN G-F 20 (SYNVISC); INTRA-ARTICULAR HYALURONIC ACID

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENZYME BIOSURGERY (RIDGEFIELD) HYLAN G-F 20 (SYNVISC); INTRA-ARTICULAR HYALURONIC ACID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Necrosis (1971); Septic Shock (2068)
Event Type  Injury  
Event Description
This unsolicited literature case from (b)(6) was received on 19-nov-2016 via literature article: kitayama h, sugiyama j, hirayama m, onada y and tsuji y.Shoulder pain after fall, septic shock, and pyomyositis associated with breast cancer chemotherapy and lymphedema.Case rep oncol 2016;9:726-732.Doi: 10.1159/000452737.This case concerns an (b)(6) female patient initiated treatment with synvisc (hylan g-f 20) and after unknown latency developed pyomyositis, necrosis of several right shoulder joint muscles, (b)(6) and catecholamine-resistant shock.It was reported that the patient had undergone a right modified radical mastectomy for breast cancer 19 years prior, and local recurrence appeared 10 years prior.After excision of the recurrence, she received adjuvant hormonal therapy, but distant metastasis recurrences were found in her right lung and pleura.Furthermore, right supraclavicular lymph node metastases made postmastectomy lymphedema worse in the same side.She also had diabetes mellitus for 9 years.She did not have chronic kidney disease.Five months prior to admission, the patient had fallen, hit her right shoulder.Further reported, the patient had received biweekly nab-paclitaxel as a palliative chemotherapy for 3 months.The chemotherapy was so effective that her right pleural effusion decreased in size.On an unknown date, the patient initiated treatment with synvisc injection (dose, route, frequency, batch/ lot number and expiration date: not provided) into the joint for frozen shoulder.On an unspecified date, latency: unknown, the patient was admitted to the hospital because the chronic right shoulder pain worsened suddenly.The pain was accompanied by catecholamine-resistant shock with bradycardia at 60/mm hg and 36 beats per minute.Electrocardiography showed atrioventricular junction rhythm, so a temporary pacemaker was inserted.On admission, the patient had no fever.Her right upper arm was not hot or fluctuant without erythema.Wbc and absolute neutrophil counts were normal (3,400 and 2,900/mcl, respectively) but higher than her usual levels during the chemotherapy without infection.The absolute neutrophil count in her nadir period was around 500- 1,000/mcl.C-reactive protein increased significantly to 19.9 mg/dl (reference range: 0.0-0.5).Creatine kinase was slightly increased to 234 iu/l (reference range: 40-170).Hemoglobin concentration and hemoglobin a1c were 8.2 g/dl and 8.2%, respectively.Serum creatinine level increased to 1.6 mg/dl (reference range: 0.4-0.8).Computed tomography (ct) scans showed swelling, increased density, and small air bubbles in the muscles surrounding her right shoulder joint.On day 2 of admission, the patient developed a high fever of up to 38â°c, erythema, tenderness, and progressive edema in the arm.Reportedly, on an unspecified date (latency: unknown), the patient was found to have methicillin-sensitive s.Aureus bacteremia.Magnetic resonance imaging (mri) revealed necrosis of several right shoulder joint muscles, showing abnormally high signal intensity in the muscles on t2-weighted and short tau inversion recovery sequence images, abnormal enhancement in some parts of the fascia, and no enhancement in the muscles.Reportedly, the patient received intravenous antimicrobial treatment with meropenem and clindamycin and intensive insulin therapy.No pus was yielded by ultrasound-guided needle aspiration from the shoulder muscles or its joint, and the patient responded well to the antimicrobial therapy, so catecholamine could be stopped.Further reported, it was difficult to rule out necrotizing fasciitis, so it was decided not to perform immediate debridement.Debridement for necrotizing fasciitis would have meant removal of large amounts of tissue from the patient's arm, and the patient would have spent the rest of her limited time (by metastatic breast cancer with carcinomatous pleurisy) bedridden with a major wound.Thus, conservative medical management considering her quality of life was continued.However, local inflammation signs persisted.Transthoracic echocardiography indicated no verruca or abscess around the heart valves.Whole-body ct scans showed no abscess, either.Due to skin disintegration and pus outflow after 2 weeks, a surgical drainage was performed.Massive pus and necrotic tissue erupted from the axilla and lateral side of the distal upper arm.Coracoid process was palpable through the axial cavity.Histological examination confirmed pyomyositis, showing severe necrosis of striated muscle and severe neutrophil infiltration.No apparent bacterial cells were identified.Pyomyositis associated with cancer chemotherapy could rapidly develop into septic shock without macroabscess, especially in breast cancer patients with lymphedema.However, the patient did not have macroabscess when she was in septic shock due to pyomyositis.Reportedly, pyomyositis was cured after definitive antimicrobial therapy for 3 weeks from the drainage.The patient was then able to restart the chemotherapy for her breast cancer which was discontinued due to the infection.Action taken: unknown.Corrective treatment: aspiration, surgical drainage, meropenem, clindamycin for pyomyositis; aspiration and surgical drainage for necrosis of several right shoulder joint muscles; meropenem and clindamycin for the events if (b)(6) and catecholamine-resistant shock outcome: recovered for the event of pyomyositis; unknown for necrosis of several right shoulder joint muscles, (b)(6) and catecholamine-resistant shock.A product technical complaint (ptc) was initiated and results were pending for the same.Reporter causality: in the opinion of the authors, mechanical damage to the skeletal muscle including fall and repeated injection most likely initiated pyomyositis.Pharmacovigilance comment: sanofi company comment dated 24-nov-2016: this literature case concerns a female patient who was hospitalized due to chronic right shoulder pain which was accompanied by septic shock with bradycardia, bacteremia, muscle necrosis and was later diagnosed with pyomyositis, which is mostly associated with an immunocompromised host.The patient had been admitted after a fall and had repeatedly been injected in joint with hyaluronic acid leading to mechanical damage which most likely initiated pyomyositis and hence, a causal role of hyaluronic acid cannot be denied in occurrence of the events.However, patient had been receiving myelosuppression therapy for breast cancer which is an additional factor for occurrence of events.
 
Event Description
This unsolicited literature case from (b)(6) was received on 19-nov-2016 via literature article: kitayama h, sugiyama j, hirayama m, onada y and tsuji y.Shoulder pain after fall, septic shock, and pyomyositis associated with breast cancer chemotherapy and lymphedema.Case rep oncol 2016;9:726-732.Doi: 10.1159/000452737.This case concerns an (b)(6) female patient initiated treatment with synvisc (hylan g-f 20) and after unknown latency developed pyomyositis, necrosis of several right shoulder joint muscles, (b)(6) and catecholamine-resistant shock.It was reported that the patient had undergone a right modified radical mastectomy for breast cancer 19 years prior, and local recurrence appeared 10 years prior.After excision of the recurrence, she received adjuvant hormonal therapy, but distant metastasis recurrences were found in her right lung and pleura.Furthermore, right supraclavicular lymph node metastases made postmastectomy lymphedema worse in the same side.She also had diabetes mellitus for 9 years.She did not have chronic kidney disease.Five months prior to admission, the patient had fallen, hit her right shoulder.Further reported, the patient had received biweekly nab-paclitaxel as a palliative chemotherapy for 3 months.The chemotherapy was so effective that her right pleural effusion decreased in size.On an unknown date, the patient initiated treatment with synvisc injection (dose, route, frequency, batch/ lot number and expiration date: not provided) into the joint for frozen shoulder.On an unspecified date, latency: unknown, the patient was admitted to the hospital because the chronic right shoulder pain worsened suddenly.The pain was accompanied by catecholamine-resistant shock with bradycardia at 60/mm hg and 36 beats per minute.Electrocardiography showed atrioventricular junction rhythm, so a temporary pacemaker was inserted.On admission, the patient had no fever.Her right upper arm was not hot or fluctuant without erythema.Wbc and absolute neutrophil counts were normal (3,400 and 2,900/mcl, respectively) but higher than her usual levels during the chemotherapy without infection.The absolute neutrophil count in her nadir period was around 500- 1,000/mcl.C-reactive protein increased significantly to 19.9 mg/dl (reference range: 0.0-0.5).Creatine kinase was slightly increased to 234 iu/l (reference range: 40-170).Hemoglobin concentration and hemoglobin a1c were 8.2 g/dl and 8.2%, respectively.Serum creatinine level increased to 1.6 mg/dl (reference range: 0.4-0.8).Computed tomography (ct) scans showed swelling, increased density, and small air bubbles in the muscles surrounding her right shoulder joint.On day 2 of admission, the patient developed a high fever of up to 38°c, erythema, tenderness, and progressive edema in the arm.Reportedly, on an unspecified date (latency: unknown), the patient was found to have (b)(6).Magnetic resonance imaging (mri) revealed necrosis of several right shoulder joint muscles, showing abnormally high signal intensity in the muscles on t2-weighted and short tau inversion recovery sequence images, abnormal enhancement in some parts of the fascia, and no enhancement in the muscles.Reportedly, the patient received intravenous antimicrobial treatment with meropenem and clindamycin and intensive insulin therapy.No pus was yielded by ultrasound-guided needle aspiration from the shoulder muscles or its joint, and the patient responded well to the antimicrobial therapy, so catecholamine could be stopped.Further reported, it was difficult to rule out necrotizing fasciitis, so it was decided not to perform immediate debridement.Debridement for necrotizing fasciitis would have meant removal of large amounts of tissue from the patient's arm, and the patient would have spent the rest of her limited time (by metastatic breast cancer with carcinomatous pleurisy) bedridden with a major wound.Thus, conservative medical management considering her quality of life was continued.However, local inflammation signs persisted.Transthoracic echocardiography indicated no verruca or abscess around the heart valves.Whole-body ct scans showed no abscess, either.Due to skin disintegration and pus outflow after 2 weeks, a surgical drainage was performed.Massive pus and necrotic tissue erupted from the axilla and lateral side of the distal upper arm.Coracoid process was palpable through the axial cavity.Histological examination confirmed pyomyositis, showing severe necrosis of striated muscle and severe neutrophil infiltration.No apparent bacterial cells were identified.Pyomyositis associated with cancer chemotherapy could rapidly develop into septic shock without macroabscess, especially in breast cancer patients with lymphedema.However, the patient did not have macroabscess when she was in septic shock due to pyomyositis.Reportedly, pyomyositis was cured after definitive antimicrobial therapy for 3 weeks from the drainage.The patient was then able to restart the chemotherapy for her breast cancer which was discontinued due to the infection.Action taken: unknown.Corrective treatment: aspiration, surgical drainage, meropenem, clindamycin for pyomyositis; aspiration and surgical drainage for necrosis of several right shoulder joint muscles; meropenem and clindamycin for the events if (b)(6) and catecholamine-resistant shock outcome: recovered for the event of pyomyositis; unknown for necrosis of several right shoulder joint muscles, (b)(6) and catecholamine-resistant shock.A product technical complaint (ptc) was initiated with global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Reporter causality: in the opinion of the authors, mechanical damage to the skeletal muscle including fall and repeated injection most likely initiated pyomyositis additional information was received on 30-nov-2016.Global ptc number with results was added and the text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 30-nov-2016: the additional information does not alter the previous case assessment.Sanofi company comment dated 24-nov-2016: this literature case concerns a female patient who was hospitalized due to chronic right shoulder pain which was accompanied by septic shock with bradycardia, bacteremia, muscle necrosis and was later diagnosed with pyomyositis, which is mostly associated with an immunocompromised host.The patient had been admitted after a fall and had repeatedly been injected in joint with hyaluronic acid leading to mechanical damage which most likely initiated pyomyositis and hence, a causal role of hyaluronic acid cannot be denied in occurrence of the events.However, patient had been receiving myelosuppression therapy for breast cancer which is an additional factor for occurrence of events.
 
Event Description
This unsolicited literature case from (b)(6) was received on 19-nov-2016 via literature article: kitayama h, sugiyama j, hirayama m, onada y and tsuji y.Shoulder pain after fall, septic shock, and pyomyositis associated with breast cancer chemotherapy and lymphedema.Case rep oncol 2016;9:726-732.Doi: 10.1159/000452737.This case concerns an (b)(6) female patient initiated treatment with synvisc (hylan g-f 20) and after unknown latency developed pyomyositis, necrosis of several right shoulder joint muscles, (b)(6) and catecholamine-resistant shock.It was reported that the patient had undergone a right modified radical mastectomy for breast cancer 19 years prior, and local recurrence appeared 10 years prior.After excision of the recurrence, she received adjuvant hormonal therapy, but distant metastasis recurrences were found in her right lung and pleura.Furthermore, right supraclavicular lymph node metastases made postmastectomy lymphedema worse in the same side.She also had had diabetes mellitus for 9 years.She did not have chronic kidney disease.Five months prior to admission, the patient had fallen, hit her right shoulder.Further reported, the patient had received biweekly nab-paclitaxel as a palliative chemotherapy for 3 months.The chemotherapy was so effective that her right pleural effusion decreased in size.On an unknown date, the patient initiated treatment with synvisc injection (dose, route, frequency, batch/ lot number and expiration date: not provided) into the joint for frozen shoulder.On an unspecified date, latency: unknown, the patient was admitted to the hospital because the chronic right shoulder pain worsened suddenly.The pain was accompanied by catecholamine-resistant shock with bradycardia at 60/mm hg and 36 beats per minute.Electrocardiography showed atrioventricular junction rhythm, so a temporary pacemaker was inserted.On admission, the patient had no fever.Her right upper arm was not hot or fluctuant without erythema.Wbc and absolute neutrophil counts were normal (3,400 and 2,900/mcl, respectively) but higher than her usual levels during the chemotherapy without infection.The absolute neutrophil count in her nadir period was around 500- 1,000/mcl.C-reactive protein increased significantly to 19.9 mg/dl (reference range: 0.0-0.5).Creatine kinase was slightly increased to 234 iu/l (reference range: 40-170).Hemoglobin concentration and hemoglobin a1c were 8.2 g/dl and 8.2%, respectively.Serum creatinine level increased to 1.6 mg/dl (reference range: 0.4-0.8).Computed tomography (ct) scans showed swelling, increased density, and small air bubbles in the muscles surrounding her right shoulder joint.On day 2 of admission, the patient developed a high fever of up to 38°c, erythema, tenderness, and progressive edema in the arm.Reportedly, on an unspecified date (latency: unknown), the patient was found to have (b)(6).Magnetic resonance imaging (mri) revealed necrosis of several right shoulder joint muscles, showing abnormally high signal intensity in the muscles on t2-weighted and short tau inversion recovery sequence images, abnormal enhancement in some parts of the fascia, and no enhancement in the muscles.Reportedly, the patient received intravenous antimicrobial treatment with meropenem and clindamycin and intensive insulin therapy.No pus was yielded by ultrasound-guided needle aspiration from the shoulder muscles or its joint, and the patient responded well to the antimicrobial therapy, so catecholamine could be stopped.Further reported, it was difficult to rule out necrotizing fasciitis, so it was decided not to perform immediate debridement.Debridement for necrotizing fasciitis would have meant removal of large amounts of tissue from the patient's arm, and the patient would have spent the rest of her limited time (by metastatic breast cancer with carcinomatous pleurisy) bedridden with a major wound.Thus, conservative medical management considering her quality of life was continued.However, local inflammation signs persisted.Transthoracic echocardiography indicated no verruca or abscess around the heart valves.Whole-body ct scans showed no abscess, either.Due to skin disintegration and pus outflow after 2 weeks, a surgical drainage was performed.Massive pus and necrotic tissue erupted from the axilla and lateral side of the distal upper arm.Coracoid process was palpable through the axial cavity.Histological examination confirmed pyomyositis, showing severe necrosis of striated muscle and severe neutrophil infiltration.No apparent bacterial cells were identified.Pyomyositis associated with cancer chemotherapy could rapidly develop into septic shock without macroabscess, especially in breast cancer patients with lymphedema.However, the patient did not have macroabscess when she was in septic shock due to pyomyositis.Reportedly, pyomyositis was cured after definitive antimicrobial therapy for 3 weeks from the drainage.The patient was then able to restart the chemotherapy for her breast cancer which was discontinued due to the infection.Action taken: unknown.Corrective treatment: aspiration, surgical drainage, meropenem, clindamycin for pyomyositis; aspiration and surgical drainage for necrosis of several right shoulder joint muscles; meropenem and clindamycin for the events if (b)(6) and catecholamine-resistant shock.Outcome: recovered for the event of pyomyositis; unknown for necrosis of several right shoulder joint muscles, (b)(6) and catecholamine-resistant shock.A product technical complaint (ptc) was initiated with global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Reporter causality: in the opinion of the authors, mechanical damage to the skeletal muscle including fall and repeated injection most likely initiated pyomyositis additional information was received on 30-nov-2016.Global ptc number with results was added and the text was amended accordingly.Follow-up information was received from the physician on 16-dec-2016: it was reported that the continuation of the investigation was impossible since the physician retired.Pharmacovigilance comment: sanofi company comment for follow up dated 30-nov-2016 and 16-dec-2016: the additional information does not alter the previous case assessment.Sanofi company comment dated 24-nov-2016: this literature case concerns a female patient who was hospitalized due to chronic right shoulder pain which was accompanied by septic shock with bradycardia, bacteremia, muscle necrosis and was later diagnosed with pyomyositis, which is mostly associated with an immunocompromised host.The patient had been admitted after a fall and had repeatedly been injected in joint with hyaluronic acid leading to mechanical damage which most likely initiated pyomyositis and hence, a causal role of hyaluronic acid cannot be denied in occurrence of the events.However, patient had been receiving myelosuppression therapy for breast cancer which is an additional factor for occurrence of events.
 
Event Description
This unsolicited literature case from japan was received on 19-nov-2016 via literature article: kitayama h, sugiyama j, hirayama m, on a da y and tsuji y.Shoulder pain after fall, septic shock, and pyomyositis associated with breast cancer chemotherapy and lymphedema.Case rep oncol 2016;9:726-732.Doi: 10.1159/000452737.This case concerns an (b)(6) years old female patient initiated treatment with synvisc (hylan g-f 20) and after unknown latency developed pyomyositis, necrosis of several right shoulder joint muscles, (b)(6) bacteremia and catecholamine-resistant shock.It was reported that the patient had undergone a right modified radical mastectomy for breast cancer 19 years prior, and local recurrence appeared 10 years prior.After excision of the recurrence, she received adjuvant hormonal therapy, but distant metastasis recurrences were found in her right lung and pleura.Furthermore, right supraclavicular lymph node metastases made postmastectomy lymphedema worse in the same side.She also had had diabetes mellitus for 9 years.She did not have chronic kidney disease.Five months prior to admission, the patient had fallen, hit her right shoulder.Further reported, the patient had received biweekly nab-paclitaxel as a palliative chemotherapy for 3 months.The chemotherapy was so effective that her right pleural effusion decreased in size.On an unknown date, the patient initiated treatment with synvisc injection (dose, route, frequency, batch/ lot number and expiration date: not provided) into the joint for frozen shoulder.On an unspecified date, latency: unknown, the patient was admitted to the hospital because the chronic right shoulder pain worsened suddenly.The pain was accompanied by catecholamine-resistant shock with bradycardia at 60/mm hg and 36 beats per minute.Electrocardiography showed atrioventricular junction rhythm, so a temporary pacemaker was inserted.On admission, the patient had no fever.Her right upper arm was not hot or fluctuant without erythema.Wbc and absolute neutrophil counts were normal (3,400 and 2,900/mcl, respectively) but higher than her usual levels during the chemotherapy without infection.The absolute neutrophil count in her nadir period was around 500-1,000/mcl.C-reactive protein increased significantly to 19.9 mg/dl (reference range: 0.0-0.5).Creatine kinase was slightly increased to 234 iu/l (reference range: 40-170).Hemoglobin concentration and hemoglobin a1c were 8.2 g/dl and 8.2%, respectively.Serum creatinine level increased to 1.6 mg/dl (reference range: 0.4-0.8).Computed tomography (ct) scans showed swelling, increased density, and small air bubbles in the muscles surrounding her right shoulder joint.On day 2 of admission, the patient developed a high fever of up to 38°c, erythema, tenderness, and progressive edema in the arm.Reportedly, on an unspecified date (latency: unknown), the patient was found to have (b)(6) bacteremia.Magnetic resonance imaging (mri) revealed necrosis of several right shoulder joint muscles, showing abnormally high signal intensity in the muscles on t2-weighted and short tau inversion recovery sequence images, abnormal enhancement in some parts of the fascia, and no enhancement in the muscles.Reportedly, the patient received intravenous antimicrobial treatment with meropenem and clindamycin and intensive insulin therapy.No pus was yielded by ultrasound-guided needle aspiration from the shoulder muscles or its joint, and the patient responded well to the antimicrobial therapy, so catecholamine could be stopped.Further reported, it was difficult to rule out necrotizing fasciitis, so it was decided not to perform immediate debridement.Debridement for necrotizing fasciitis would have meant removal of large amounts of tissue from the patient's arm, and the patient would have spent the rest of her limited time (by metastatic breast cancer with carcinomatous pleurisy) bedridden with a major wound.Thus, conservative medical management considering her quality of life was continued.However, local inflammation signs persisted.Transthoracic echocardiography indicated no verruca or abscess around the heart valves.Whole-body ct scans showed no abscess, either.Due to skin disintegration and pus outflow after 2 weeks, a surgical drainage was performed.Massive pus and necrotic tissue erupted from the axilla and lateral side of the distal upper arm.Coracoid process was palpable through the axial cavity.Histological examination confirmed pyomyositis, showing severe necrosis of striated muscle and severe neutrophil infiltration.No apparent bacterial cells were identified.Pyomyositis associated with cancer chemotherapy could rapidly develop into septic shock without microabscess, especially in breast cancer patients with lymphedema.However, the patient did not have microabscess when she was in septic shock due to pyomyositis.Reportedly, pyomyositis was cured after definitive antimicrobial therapy for 3 weeks from the drainage.The patient was then able to restart the chemotherapy for her breast cancer which was discontinued due to the infection.Action taken: unknown.Corrective treatment: aspiration, surgical drainage, meropenem, clindamycin for pyomyositis; aspiration and surgical drainage for necrosis of several right shoulder joint muscles; meropenem and clindamycin for the events if (b)(6) bacteremia and catecholamine-resistant shock.Outcome: recovered for the event of pyomyositis; unknown for necrosis of several right shoulder joint muscles, (b)(6) bacteremia and catecholamine-resistant shock a product technical complaint (ptc) was initiated with global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Genzyme global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi genzyme bio-surgery would continue to monitor adverse events to determine if a capa was required.Reporter causality: in the opinion of the authors, mechanical damage to the skeletal muscle including fall and repeated injection most likely initiated pyomyositis additional information was received on 30-nov-2016.Global ptc number with results was added and the text was amended accordingly.Follow-up information was received from the physician on 16-dec-2016: it was reported that the continuation of the investigation was impossible since the physician retired.Additional information was received on 24-jan-2017 from a physician.As hyaluronic acid injection, artz and suvenyl were available but synvisc was not available at the reporting hospital.Additionally, it was reported that the continuation of the investigation was impossible as the reporter in the previous report no longer worked for the reporting hospital and the reporter in this report (and other authors of the literature article at the reporting hospital) was too busy to provide cooperation.Pharmacovigilance comment: sanofi company comment for follow up dated 24-jan-2017: the additional information does not alter the previous case assessment.Sanofi company comment dated 24-nov-2016: this literature case concerns a female patient who was hospitalized due to chronic right shoulder pain which was accompanied by septic shock with bradycardia, bacteremia, muscle necrosis and was later diagnosed with pyomyositis, which is mostly associated with an immunocompromised host.The patient had been admitted after a fall and had repeatedly been injected in joint with hyaluronic acid leading to mechanical damage which most likely initiated pyomyositis and hence, a causal role of hyaluronic acid cannot be denied in occurrence of the events.However, patient had been receiving myelosuppression therapy for breast cancer which is an additional factor for occurrence of events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HYLAN G-F 20 (SYNVISC)
Type of Device
INTRA-ARTICULAR HYALURONIC ACID
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
55b-220a
bridgewater, NJ 08807
9089817289
MDR Report Key6138695
MDR Text Key61232480
Report Number2246315-2016-00180
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PACLITAXEL(CON.)
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
-
-