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

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Rigid abdomen/chest symptoms abdominal rigidity.Chest symptoms chest discomfort.Synvisc one was administered in shoulder (left) [product administered at inappropriate site.Synvisc one was administered along with aristopan wrong technique in device usage process.Case narrative: this case is linked to cases (b)(4) (multiple devices).Initial information received on 21-mar-2022 regarding a solicited valid serious case from other health professional, in the scope of post-marketing sponsored study "(b)(6)".Patient id: (b)(6); country: (b)(6).Study title: patient support program involving synvisc one.This case involves a (b)(6) male patient who experienced rigid abdomen, chest symptoms, after being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].Also, synvisc one was administered in shoulder (left) and synvisc one was administered along with aristopan.The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had multiple medical and orthopedic comorbidities.The patient was retired some 30 years ago with multiplicity of medical and surgical problems, returned for review of bilateral shoulder tendinopathy provoked by constant use of forearm cane symptoms for the past 25 years, secondary ataxic gait pattern-all dating back to lower spine injuries sustained when he was ejected out of his t-33 jet trainer in manitoba 1968-i.E.Use of forearm canes that converted his shoulders into weight bearing joints-i.E.(that is) care of such should be covered by dva (full form not specified).Required at least 3 major lumbar spine procedures including decompression/ instrumentation/ fusion to 1969, revision instrumentation and fusion l3-4 (lumbar) (b)(6) 1984 and using ccd [compact cotrel dubousset instrumentation] with bone graft left posterior iliac crest.Protracted recovery weaned off narcotics by (b)(6) 1994, but secondary ataxic type gait using forearm canes.But then his ataxic type gait, using forearm canes.Always had tolerable intrascapular back pain.The patient had concurrent oa (osteoarthritis) knees-originally injured trying to move 300 pounds cart at work in the navy-6 open ors, 3 scopes for medial and lateral meniscectomies/patellectomy right knee, eventual right tkr (total knee replacement) on (b)(6) 2006-right knee always weak/a bit sore.Right knee has always felt loose and weaker but did regain satisfactory 15-100 stable rom (range of motion).Concurrent overuse of left knee with compensatory left knee oa, requiring scope and debridement on (b)(6) 2012 for advanced/bare bone grade 3 cmp (full form not specified)/large and small loose bodies/extensive medial oa fragmentation/intact menisci/satisfactory stable 15-130.Postop good but with diminishing effect from grease jobs, requiring eventual left tkr (total knee replacement) in 2015.Patent was further compromised by left drop foot after his revision spine procedure (b)(6) 2021- making him more dependent upon his forearm canes and provoking overuse problems with his shoulders okay with regular grease jobs most recently his 16th with synvisc and aristospan (b)(6) 2020.Clinically unchanged, slow swing-through gait using bilateral forearm canes; shoulder still look normal/ symmetrical with diffuse subacromial tenderness posterior and anteriorly without crepitus through satisfactory stable er (emergency room)/abduction 35/70.Concomitant medications included hyaluronic acid (durolane); and triamcinolone hexacetonide (aristospan).On (b)(6) 2021, the patient received (17th) hylan g-f 20, sodium hyaluronate injection in left shoulder at dose of 2 ml in left shoulder (product administered at inappropriate site, latency; same day) (indication, lot, route, frequency - unknown).Reportedly, with appropriate sterile and covid prevention technique through posterior subacromial approach his right followed by left injection with 1 cc trispan [aristospan]/3 cc local/2 cc synvisc sj (wrong technique in device usage process, latency: same day) and it was tolerated well.Post injection routine was reviewed with him, was to be repeat in (b)(6)2021.In his visit of (b)(6) 2021, the patient mentioned that durolane/trispan helped but only for 2 to 3 months of his right shoulder, 4-5 months of his left.Since an unknown date in 2021, after unknown latency, the patient was compromised after spending a week at hospital for rigid abdomen (abdominal rigidity) /chest symptoms (chest discomfort) for which he was discharged (b)(6) 2021 with no significant abnormalities found.Clinically shoulders good for him, using forearm canes well, no asymmetry, moderate subacromial tenderness crepitus each on direct palpation, with good resisted er/abduction 40/70 bilaterally.Action taken: not applicable for all the events.It was not reported if the patient received a corrective treatment for the events.At time of reporting, the outcome was unknown for all the events.Reporter causality: not reported for all the events.Company causality: not reportable for all the events.A product technical compliant (ptc) was initiated, and results were pending for the same.

Event Description

Rigid abdomen/chest symptoms [abdominal rigidity] chest symptoms [chest discomfort] synvisc one was administered in shoulder (left) [product administered at inappropriate site] synvisc one was administered along with aristopan [wrong technique in device usage process] case narrative: this case is linked to cases (b)(6) (multiple devices) initial information received on 21-mar-2022 regarding a solicited valid serious case from other health professional, in the scope of post-marketing sponsored study (b)(6).Patient id:(b)(6).Study title: (b)(6).This case involves a 73 years old male patient who experienced rigid abdomen, chest symptoms, after being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc one].Also, synvisc one was administered in shoulder (left) and synvisc one was administered along with aristopan the patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had multiple medical and orthopedic comorbidities.The patient was retired some 30 years ago with multiplicity of medical and surgical problems, returned for review of bilateral shoulder tendinopathy provoked by constant use of forearm cane symptoms for the past 25 years, secondary ataxic gait pattern-all dating back to lower spine injuries sustained when he was ejected out of his t-33 jet trainer in manitoba 1968-i.E.Use of forearm canes that converted his shoulders into weight bearing joints-i.E.(that is) care of such should be covered by dva (full form not specified).Required at least 3 major lumbar spine procedures including decompression/ instrumentation/ fusion to 1969, revision instrumentation and fusion l3-4 (lumbar) 07-december-1984 and using ccd [compact cotrel dubousset instrumentation] with bone graft left posterior iliac crest.Protracted recovery weaned off narcotics by december-1994, but secondary ataxic type gait using forearm canes.But then his ataxic type gait, using forearm canes.Always had tolerable intrascapular back pain.The patient had concurrent oa (osteoarthritis) knees-originally injured trying to move 300 pounds cart at work in the navy-6 open ors, 3 scopes for medial and lateral meniscectomies/patellectomy right knee, eventual right tkr (total knee replacement) on 30-oct-2006-right knee always weak/a bit sore.Right knee has always felt loose and weaker but did regain satisfactory 15-100 stable rom (range of motion).Concurrent overuse of left knee with compensatory left knee oa, requiring scope and debridement on (b)(6) 2012 for advanced/bare bone grade 3 cmp (full form not specified)/large and small loose bodies/extensive medial oa fragmentation/intact menisci/satisfactory stable 15-130.Postop good but with diminishing effect from grease jobs, requiring eventual left tkr (total knee replacement) in 2015.Patent was further compromised by left drop foot after his revision spine procedure (b)(6) 201- making him more dependent upon his forearm canes and provoking overuse problems with his shoulders okay with regular grease jobs most recently his 16th with synvisc and aristospan (b)(6) 2020.Clinically unchanged, slow swing-through gait using bilateral forearm canes; shoulder still look normal/ symmetrical with diffuse subacromial tenderness posterior and anteriorly without crepitus through satisfactory stable er (emergency room)/abduction 35/70.Concomitant medications included hyaluronic acid (durolane); and triamcinolone hexacetonide (aristospan).On (b)(6) 2021, the patient received (17th) hylan g-f 20, sodium hyaluronate injection (48 mg/6ml) in left shoulder at dose of 2 ml in left shoulder (product administered at inappropriate site, latency; same day) (indication, lot, route, frequency - unknown).Reportedly, with appropriate sterile and covid prevention technique through posterior subacromial approach his right followed by left injection with 1 cc trispan [aristospan]/3 cc local/2 cc synvisc sj (wrong technique in device usage process, latency: same day) and it was tolerated well.Post injection routine was reviewed with him, was to be repeat in (b)(6) 2021.In his visit of (b)(6) 2021, the patient mentioned that durolane/trispan helped but only for 2 to 3 months of his right shoulder, 4-5 months of his left.Since an unknown date in 2021, after unknown latency, the patient was compromised after spending a week at hospital for rigid abdomen (abdominal rigidity) /chest symptoms (chest discomfort) for which he was discharged (b)(6) 2021 with no significant abnormalities found.Clinically shoulders good for him, using forearm canes well, no asymmetry, moderate subacromial tenderness crepitus each on direct palpation, with good resisted er/abduction 40/70 bilaterally.Action taken: not applicable for all the events it was not reported if the patient received a corrective treatment for the events at time of reporting, the outcome was unknown for all the events reporter causality: not reported for all the events company causality: not reportable for all the events product technical complaint (ptc) was initiated with global ptc number 100222726 on 04-may-2022 for synvisc one.Batch number: unknown the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.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 ncr (non-conformance) process.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.This review has not indicated any safety issue.Sanofi will continue to monitor complaints to determine if a capa is required.The final investigation was completed on 29-jul-2022 with summarized conclusion as no assessment possible.Additional information was received on 29-jul-2022 from other healthcare professional (from quality department).Gptc results were received and added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• 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 Key: 13965319
• MDR Text Key: 288290161
• Report Number: 2246315-2022-00028
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Number: 1
• Treatment: ARISTOSPAN (TRIAMCINOLONE HEXACETONIDE),UNKNOWN; ARISTOSPAN (TRIAMCINOLONE HEXACETONIDE),UNKNOWN; DUROLANE (HYALURONIC ACID),UNKNOWN; DUROLANE (HYALURONIC ACID),UNKNOWN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 79 KG