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

Lot Number UNKNOWN

Device Problem Human Factors Issue (2948)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 16-aug-2017 from the other non-health care professional (provider).This case concerns a male patient (age unspecified) who received treatment with synvisc injection and after unknown latency the patient ended up needing a total knee replacement and had suspicion of chicken allergy.No relevant medical history, past drugs and concomitant medications were reported.On an unknown date, the patient received treatment with intra-articular synvisc injection (dose, frequency, indication, lot number and expiration date: not reported).On an unknown date, unknown latency of receiving the injection the patient ended up needing a total knee replacement but the suspicion was that this was related to a chicken allergy.The reporter mentioned that it was not a confirmed chicken allergy but that was the suspicion at the practice.Action taken: drug withdrawn nos corrective treatment: not reported for both outcome: unknown for suspicion of chicken allergy a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criterion: important medical event for ended up needing a total knee replacement pharmacovigilance comment: sanofi company comment dated 21-aug-2017: this case concerns a patient who received treatment with synvisc and ended up having total knee replacement.The causal role of suspect product in occurrence of the event cannot be established due to lack of information regarding underlying reason for knee replacement.Furthermore, due to lack of information regarding medical history, concurrent conditions and past drugs precludes complete medical assessment of the case.

Event Description

This unsolicited case from united states was received on (b)(6) 2017 from the other non-health care professional (provider).This case concerns a male patient (age unspecified) who received treatment with synvisc injection and after unknown latency the patient ended up needing a total knee replacement and had suspicion of chicken allergy.No relevant medical history, past drugs and concomitant medications were reported.On an unknown date, the patient received treatment with intra-articular synvisc injection (dose, frequency, indication, lot number and expiration date: not reported).On an unknown date, unknown latency of receiving the injection the patient ended up needing a total knee replacement but the suspicion was that this was related to a chicken allergy.The reporter mentioned that it was not a confirmed chicken allergy but that was the suspicion at the practice.Action taken: drug withdrawn nos.Corrective treatment: not reported for both.Outcome: unknown for suspicion of chicken allergy.A pharmaceutical 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.Sanofi 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 would continue to monitor adverse events to determine if a capa was required.Seriousness criterion: important medical event for ended up needing a total knee replacement additional information was received on 28-aug-2017.Global ptc number and ptc results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2017: this case concerns a patient who received treatment with synvisc and ended up having total knee replacement.The causal role of suspect product in occurrence of the event cannot be established due to lack of information regarding underlying reason for knee replacement.Furthermore, lack of information regarding medical history, concurrent conditions and past drugs precludes complete medical assessment of the case.

• Brand Name: 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 Key: 6834543
• MDR Text Key: 84258486
• Report Number: 2246315-2017-00132
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

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: Other
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 08/28/2017
• Supplement Dates FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other