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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Event Description
Septic arthritis with rapid progressive destruction of the femoral head (right side hip) [septic arthritis nos] ([immobile], [subluxation hip], [fever], [reduced general condition], [osteolysis], [osteonecrosis], [pain in hip]).Case narrative: initial information received on 24-may-2023 via health care professional from germany regarding an unsolicited valid serious case issued from a literature article freigang v, baumann f, alt v.Bilateral septic arthritis with rapid progressive destruction of the femoral head after joint injection in rheumatoid arthritis.J bone joint infect.2021;6(7):255-6.Available from: https://doi.Org/10.5194/jbji-6-255-2021.This case is linked to (b)(6) (same patient, multiple device use).This case involves a 61 years old patient (gender not reported) who experienced septic arthritis with rapid progressive destruction of the femoral head (right side hip) while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) or (synvisc one) (latency: unknown).The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient with steroid therapy for rheumatoid arthritis and had pain in the groin on both sides (concurrent condition).On an unknown date, twelve weeks before the first consultation in institution, an orthopedic surgeon revealed the diagnosis of advanced osteoarthritis of the hip on both sides (concurrent condition) and injected hyaluronic acid of dosage form solution for injection via route intraarticular (dose, strength, frequency, batch number/lot number, expiry date: unspecified) in right side hip joint.Subsequently, the pain increased (arthralgia), leading to immobility (immobile) and poor general condition (general physical health deterioration).Twelve weeks after the injection, the patient presented to emergency department with fever (pyrexia), reduced general condition and pain in right side hip.On admission, the patient's c-reactive protein level (crp) level was 371 mg/l and the white blood cell (wbc) count was 17.3 per nanolitre.The x-ray of the pelvis shows rapid progressive destruction of right side hip joint/femoral head necrosis on right side hip with extensive osteolysis (osteonecrosis) (osteolysis), a subluxation (joint dislocation) and an acetabular bony defect of the right side/bone loss.The patient was diagnosed with septic arthritis with rapid progressive destruction of the femoral head (right side hip) (arthritis bacterial).The patient received emergent surgical debridement of right side hip joint and implantation of antibiotic-coated articular spacers.After treatment of the infection with repeated debridement and spacer exchange, implanted a silver-coated non cemented standard prosthesis on right side hip.The author reported a clinical case of rapid progressive destruction of the femoral head caused by infection after joint injection in rheumatoid arthritis.Further, recommend a strict risk-benefit analysis before intraarticular application of hyaluronic acid in patients with rheumatoid arthritis and long-term steroid therapy.Action taken: not applicable.Corrective treatment: emergent surgical debridement of right side hip joint and implantation of antibiotic-coated articular spacers, repeated debridement and spacer exchange, implanted a silver-coated non cemented standard prosthesis on right side hip.Outcome: recovering/resolving.Seriousness criteria: medically significant, hospitalization and disability.Reporter causality: related.A significant amendment has been performed with receipt date 24-may-2023: to add the brand name of suspect drug as synvisc (no hyaluronic acid visco-supplement brand name was reported in the article publication.Hence, it is captured under synvisc in a conservative approach).
 
Event Description
Septic arthritis with rapid progressive destruction of the femoral head (right side hip) [septic arthritis nos] ([immobile], [subluxation hip], [fever], [reduced general condition], [osteolysis], [osteonecrosis], [pain in hip]) case narrative: initial information received on 24-may-2023 via health care professional from germany regarding an unsolicited valid serious case issued from a literature article freigang v, baumann f, alt v.Bilateral septic arthritis with rapid progressive destruction of the femoral head after joint injection in rheumatoid arthritis.J bone joint infect.2021;6(7):255-6.Available from: https://doi.Org/10.5194/jbji-6-255-2021.This case is linked to (b)(4) (same patient, multiple device use).This case involves a 61 years old patient (gender not reported) who experienced septic arthritis with rapid progressive destruction of the femoral head (right side hip) while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) or (synvisc one) (latency: unknown).The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient with steroid therapy for rheumatoid arthritis and had pain in the groin on both sides (concurrent condition).On an unknown date, twelve weeks before the first consultation in institution, an orthopedic surgeon revealed the diagnosis of advanced osteoarthritis of the hip on both sides (concurrent condition) and injected hyaluronic acid of dosage form solution for injection via route intraarticular (dose, strength, frequency, batch number/lot number, expiry date: unspecified) in right side hip joint.Subsequently, the pain increased (arthralgia), leading to immobility (immobile) and poor general condition (general physical health deterioration).Twelve weeks after the injection, the patient presented to emergency department with fever (pyrexia), reduced general condition and pain in right side hip.On admission, the patient's c-reactive protein level (crp) level was 371 mg/l and the white blood cell (wbc) count was 17.3 per nanolitre.The x-ray of the pelvis shows rapid progressive destruction of right side hip joint/femoral head necrosis on right side hip with extensive osteolysis (osteonecrosis) (osteolysis), a subluxation (joint dislocation) and an acetabular bony defect of the right side/bone loss.The patient was diagnosed with septic arthritis with rapid progressive destruction of the femoral head (right side hip) (arthritis bacterial).The patient received emergent surgical debridement of right side hip joint and implantation of antibiotic-coated articular spacers.After treatment of the infection with repeated debridement and spacer exchange, implanted a silver-coated non cemented standard prosthesis on right side hip.The author reported a clinical case of rapid progressive destruction of the femoral head caused by infection after joint injection in rheumatoid arthritis.Further, recommend a strict risk-benefit analysis before intraarticular application of hyaluronic acid in patients with rheumatoid arthritis and long-term steroid therapy.Action taken: not applicable corrective treatment: emergent surgical debridement of right side hip joint and implantation of antibiotic-coated articular spacers, repeated debridement and spacer exchange, implanted a silver-coated non cemented standard prosthesis on right side hip outcome: recovering/resolving seriousness criteria: medically significant, hospitalization and disability reporter causality: related a significant amendment has been performed with receipt date 24-may-2023: to add the brand name of suspect drug as synvisc in the product tab (no hyaluronic acid visco-supplement brand name was reported in the article publication.The company tried to obtain an answer from the author and the mails sent on 05-jun-2023, 05-jul-2023 remained unanswered.Hence, it is captured under synvisc in product tab and synvisc or synvisc one brands in narrative in a conservative approach).A product technical complaint (ptc) was initiated on 24-may-2023 for synvisc (lot/batch number: unknown) with global ptc number: 100349181.The sample status and picture status of the ptc was not available.The ptc stated, preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class has been updated to ii.Investigation: the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a corrective and preventive action (capa) is required.The final investigation was completed on 18-aug-2023 with summarized conclusion as no assessment possible.Additional information was received on 18-aug-2023 via other health care professional from quality department: ptc details were added.Text amended accordingly.
 
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Brand Name
SYNVISC
Type of Device
MOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key17449683
MDR Text Key320289649
Report Number2246315-2023-00085
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/03/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Disability; Required Intervention; Hospitalization;
Patient Age61 YR
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