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 Extravasation (1842); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Arthralgia (2355); Reaction, Injection Site (2442)

Event Date 05/10/2012

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment for follow up dated 23-dec-2020: follow up information does not change previous assessment of the case.This case involves a female patient who had synvisc one injection and had severe antigen antibody reaction, very restricted activity and 1cc went into knee 1 cc outside knee into system leading to permanent impairment/disability.Based on the available information, causal relationship between the event and suspect product could not be denied.However, patient had history of osteoarthritis and torn cartilage which could contribute to the events.As reported that 1cc of the injection went outside the knee which also indicates possibility of incorrect injection technique as well and further information regarding the same and also concomitant medications would aid better case assessment.

Event Description

1cc went into knee 1 cc outside knee into system [injection site extravasation] very restricted activity [decreased activity].Cascade of horrific problems and a significant impact on lifestyle as a result of pain and inflammation that impairs movement a lot [movements reduced].Severe antigen antibody reaction [immune complex reaction] ([injection site joint inflammation], [injection site joint pain]).Case narrative: initial information received on 14-dec-2020 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference mw5097911.The case was cross referenced with (b)(4) (multiple devices: case for first injection).This case involves an unknown age patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one) and 1cc went into knee 1 cc outside knee into system, very restricted activity, severe antigen antibody reaction and cascade of horrific problems and a significant impact on lifestyle as a result of pain and inflammation that impairs movement a lot.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Patient reported that the primary problem was significant pain and osteoarthritis of right knee and patient also had a torn cartilage back in the 70's (1970).Surgery was done and this was just before arthroscopy on the inside.The orthopod was uncertain if the outside was also torn and they opted to not do surgery, sadly that was a big mistake, because that's where patient had all of the problems.It was reported that current pictures of the inside look great where the surgery was done, but the outside was really torn up.It was reported that arthroscopic surgery was done to try to improve the function sadly, it got worse instead of better, and thus the hylan g-f 20, sodium hyaluronate injections were then tried.Patient received 1 hylan g-f 20, sodium hyaluronate injection one year prior to current one (in 2011).On (b)(6) 2012, the patient started using intra-articular injection of hylan g-f 20, sodium hyaluronate (lot, dose, frequency: unknown) for significant pain and osteoarthritis of right knee.There will be no information available on the batch number for this case.It was reported that unfortunately 1cc went into knee and 1 cc outside knee into system (injection site extravasation, onset: (b)(6) 2012, latency: same day) and patient had a severe antigen antibody reaction (type iii immune complex mediated reaction, onset: (b)(6) 2012, latency: same day) according to the doctor and began a cascade of horrific problems and a significant impact on lifestyle as a result of pain (injection site joint pain, onset: 2012, latency: unknown) and inflammation (injection site joint inflammation, onset: 2012, latency: unknown) that impairs movement a lot (hypokinesia, onset: 2012, latency: unknown).Despite high dose steroids, intensive treatment by a top rheumatologist for the intense inflammation and pain, patient was never the same or gotten rid of the chronic pain that resulted.Patient was a healthy active guy before this, and now had very restricted activity (decreased activity, onset: 2012, latency: unknown).Event of injection site extravasation was assessed as serious due to required intervention and was leading to disability, events of decreased activity and hypokinesia was assessed as serious due to disability and event of type iii immune complex mediated reaction was assessed as serious due to required intervention, disability and was medically significant.Patient wanted to know if there was any way to get it out of the system, like chelation or some other method, the cc that went into the knee was removed within a few weeks, but the problems were caused by the systemic cc.Patient was living on ibuprofen (motrin) 800 mg tid or when it becomes intolerable methylprednisolone (medrol dosepak).Action taken: not applicable for all events.Corrective treatment: high dosses of steroids, ibuprofen (motrin), methylprednisolone (medrol dosepak) for type iii immune complex mediated reaction and injection site extravasation, not reported for rest of the events.Outcome: unknown for decreased activity, hypokinesia and type iii immune complex mediated reaction, not recovered for the rest of the events.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc one for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.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 (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 23-dec-2020.Follow up was received on 14-dec-2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 23-dec-2020 from healthcare professional.Investigational results were added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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 Key: 11073458
• MDR Text Key: 231132306
• Report Number: 2246315-2020-00177
• 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: health professional
• Type of Report: Initial
• Report Date: 12/25/2020

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
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/25/2020
• 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
• Patient Outcome(s): Other; Required Intervention; Disability