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

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 12/01/2014

Event Type  No Answer Provided  

Event Description

This unsolicited device case from united states was received on 30-sep-2015.This case concerns a male patient of unspecified age who started treatment with synvisc into his right shoulder and it did not work (therapeutic product ineffective for unapproved indication) and he had successful reverse shoulder replacement.No medical history, past drugs, concurrent conditions or concomitant medications were reported.On an unknown date in 2014 ((b)(6) 2014), the patient received treatment with 3 intra-articular synvisc injections, with imaging (dose, frequency, batch/lot number and expiration date: not provided) into his right shoulder to treat osteoarthritis.It was reported that synvisc did not work.Also, on an unknown date in (b)(6)-2014, he had successful reverse shoulder replacement.Corrective treatment: not reported for successful reverse shoulder replacement.Outcome: unknown for successful reverse shoulder replacement.A pharmaceutical technical complaint was initiated with global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is 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 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 had not indicated any safety issue.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: important medical event for successful reverse shoulder replacement additional information was received on 08-oct-2015: global ptc number and ptc results were added.Pharmacovigilance comment: sanofi company comment dated 08-oct-2015: based on the follow information, the overall case assessment remains unchanged.Sanofi company comment dated 07-oct-2015: this case involves a male patient who received treatment with synvisc in right shoulder and underwent successful reverse shoulder replacement.Based on the temporal relationship, the causal relationship cannot be ruled out.However, it is highly unlikely that the product could have played role in shoulder replacement surgery.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5152760
• MDR Text Key: 28371464
• Report Number: 2246315-2015-98574
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Report Date: 09/30/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• 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
• Patient Age: 71 YR