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

Lot Number UNKNOWN

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

Patient Problems Erythema (1840); Arthralgia (2355); Peripheral Edema (4578)

Event Date 01/26/2023

Event Type  Injury  

Event Description

45 cc's of fluid build up on her knee [injection site joint effusion] more redness (right knee) [injection site joint erythema] ([condition aggravated]) severe pain (right knee) [injection site joint pain] swelling (right knee) [injection site joint swelling] right arm and legs were achy and sore [pain in extremity] back were achy and sore [back pain] bones were aching [bone pain].Case narrative: this case is linked to case id (b)(4) (multiple device suspect used for the same patient).Initial information was received from the united states on 02-feb-2023 regarding an unsolicited valid serious case received from the patient.This case involves a 72 years old female patient who reported right arm and legs were achy and sore, back were achy and sore, 45 cc's of fluid on her knee, more redness, severe pain and swelling while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, vaccination(s), and family history were not provided.The patient first injection of series of (b)(6) 2023, and second injection of series on (b)(6) 2023.On (b)(6) 2023, the patient received synvisc 3 rd injection in right knee (lot, expiry date, strength, dose, route, frequency - unknown) for osteoarthritis.Information on batch number was requested.On (b)(6) 2023 after a latency of same day patient severe pain (injection site joint pain) (intervention required) more redness (injection site joint erythema) (condition aggravated) (intervention required) and swelling (injection site joint swelling) with 45 cc's of fluid build up on her knee (injection site joint effusion)(intervention required), she states that her right arm, back, and leg were achy and sore (pain in extremity) (back pain).Said that the doctor provided her with pain killers that were stronger than the ibuprofen she was previously taking and also administered a cortisone shot.The physician explained that the product could be a bad lot number.Symptoms are still present but gradually improving.Patient did not have lot number and expiration date, but stated that she believed her provider already reported a possible bad lot number due to seeing this problem in several patients.Patient suspected a bad batch of the product.Patient stated that it felt her bones were aching.(bone pain) relevant laboratory test results included: fluid retention - on (b)(6) 2023: [45 cc's of fluid on her knee].Action taken: not applicable for all the events.Corrective treatment: painkillers and cortisone shots, ibuprofen was received for all the events.Outcome: recovering/resolving for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 10-feb-2023: this case involves a 72 years old female patient who reported 45 cc's of fluid on her knee, more redness, severe pain and swelling while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

45 cc's of fluid build up on her knee [injection site joint effusion].More redness (right knee) [injection site joint erythema] ([condition aggravated]).Severe pain (right knee) [injection site joint pain].Swelling (right knee) [injection site joint swelling] right arm and legs were achy and sore [pain in extremity].Back were achy and sore [back pain].Bones were aching [bone pain].Case narrative: this case is linked to case id (b)(6) (multiple device suspect used for the same patient).Initial information was received from the united states on 02-feb-2023 regarding an unsolicited valid serious case received from the patient.This case involves a 72 years old female patient who reported right arm and legs were achy and sore, back were achy and sore, 45 cc's of fluid on her knee, more redness, severe pain and swelling while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, vaccination(s), and family history were not provided.The patient first injection of series of (b)(6) 2023, and second injection of series on (b)(6) 2023.On (b)(6) 2023, the patient received synvisc 3 rd injection in right knee (lot, expiry date, strength, dose, route, frequency - unknown) for osteoarthritis.Information on batch number was requested.On (b)(6) 2023 after a latency of same day patient severe pain (injection site joint pain) (intervention required) more redness (injection site joint erythema) (condition aggravated) (intervention required) and swelling (injection site joint swelling) with 45 cc's of fluid build up on her knee (injection site joint effusion)(intervention required), she states that her right arm, back, and leg were achy and sore (pain in extremity) (back pain).Said that the doctor provided her with pain killers that were stronger than the ibuprofen she was previously taking and also administered a cortisone shot.The physician explained that the product could be a bad lot number.Symptoms are still present but gradually improving.Patient did not have lot number and expiration date, but stated that she believed her provider already reported a possible bad lot number due to seeing this problem in several patients.Patient suspected a bad batch of the product.Patient stated that it felt her bones were aching.(bone pain) relevant laboratory test results included: fluid retention - on (b)(6) 2023: [45 cc's of fluid on her knee].Action taken: not applicable for all the events corrective treatment: painkillers and cortisone shots, ibuprofen was received for all the events.Outcome: recovering/resolving for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.Upon internal review on 02-jun-2023, the case (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).All the information from the case (b)(4) (to be deleted) has been merged in the case (b)(4) (to be retained).Hence deleted from the database.

Manufacturer Narrative

Sanofi company comment dated 10-feb-2023: this case involves a 72 years old female patient who reported 45 cc's of fluid on her knee, more redness, severe pain and swelling while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

• Brand Name: SYNVISC
• 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: 16360862
• MDR Text Key: 309370242
• Report Number: 2246315-2023-00016
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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 Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2023
• 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): Required Intervention
• Patient Sex: Female