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

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

Patient Problems Pain (1994); Weakness (2145); No Code Available (3191)

Event Date 06/01/2018

Event Type  Injury  

Event Description

He was walking with a cane and now he is walking with a walker [walking difficulty].Couldn't put any weight on his leg [weight bearing difficulty].Doesn't have any strength [strength loss of].Pain/ it is very painful [knee pain].Case narrative: initial information was received on 11-jun-2018 regarding this unsolicited case from united states via a consumer.This case involves a (b)(6) male patient who experienced pain/ it is very painful (latency: one day), couldn't put any weight on his leg, he was walking with a cane and now he is walking with a walker and doesn't have any strength (latency: unknown), after he received hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2018, the patient received intra-articular hylan g-f 20, sodium hyaluronate (synvisc one), once at a dose of 6 ml for osteoarthritis.On (b)(6) 2018, the patient developed pain/ it is very painful.On an unknown date in (b)(6) 2018, the patient couldn't put any weight on his leg, he was walking with a cane and now he is walking with a walker and doesn't have any strength.It was also reported that the patient was not experiencing any swelling and when he was sitting down it did not hurt.A product technical complaint (ptc) was initiated on 13-jun-2018 for "synvisc one".Batch number unknown, global ptc number: (b)(4).The reporter stated that the device caused "pain, couldn't put any weight on leg, doesn't have any strength, was walking with cane and now walking with a walker" that resulted in "arthralgia, asthenia, weight bearing difficulty, gait disturbance".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.All finished batch records for specification conformance prior to release were reviewed as per the requirement.Any out of specification result need to be identified and mitigated through the ncr process.Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals.Final investigation complete date was 13-jun-2018.No safety issues were indicated in this review.Corrective treatment: walker for he was walking with a cane and now he is walking with a walker and not reported for the rest.Outcome: unknown.Seriousness criteria: disability.Additional information on (b)(6) 2018 was received in the form of investigation summary.Gptc number added.Clinical course was updated and text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8199950
• MDR Text Key: 131519605
• Report Number: 2246315-2018-00833
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2018
• 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
• Patient Outcome(s): Disability
• Patient Age: 83 YR