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

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Eye Injury (1845); Bone Fracture(s) (1870); Perforation (2001)

Event Date 12/25/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 27-dec-2017 from a consumer (patient's mother).This case concerns a (b)(6) female patient who received treatment with synvisc one and later after few days had broken rib, punctured lung, black eye, fell, after unknown latency, legs were weak, couldn't walk, couldn't bend her knees, injection was very painful and felt like she had concrete in her knees and had pain in knees (latency few hours).Also device malfunction was identified for the reported lot number.No concomitant medication or concurrent condition was provided.The patient had past treatment with cortisone.The patient had medical history of knee problems in general.On an unknown date in 2017 (8 weeks ago from (b)(6) 2017), the patient initiated treatment with intraarticular synvisc one injection at a dose of 1 df once for knee osteoarthritis (batch/lot number: 7rsl021, expiry date: unknown).At the time of the injection it was very painful and there was no anesthetic used (but may be an antibiotic was given before the injection but not confirmed).The same day, within few hours the patient developed excruciating pain in her knees.It was reported that the patient was suffering real bad and that she called her doctor after 3 days and they informed her to wait as it might get better.She states that they then called again and were told to wait longer.It was reported that the pain had started to go away, but then they received a call from their doctor's office that she received the recalled lot.On an unknown date in 2017, after unknown latency, the pain was bad and she couldn't walk and it felt like she had concrete in her knees (latency: unknown).On an unknown date in 2017, after unknown latency the patient couldn't bend her knees or even walk to go to the bathroom.There was no physical activity done after the injection.It was reported that the patient had been having minor falls since the injection because her legs were now weak and unstable (event onset date: 2017; latency: unknown).On (b)(6) 2017 at night the patient had a serious fall and had to go to the hospital.The same day, the patient suffered with a broken rib, punctured lung, and a black eye.It is reported that she was currently in the hospital and she had been prescribed bactrim.It was reported that the patient's overall knee pain has improved, but knee had not returned to the function it had prior to the injection.Corrective treatment: not reported for all the events outcome: recovering for device malfunction and pain in knees; unknown for rest of the events an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criteria: hospitalization/prolongation for broken rib, punctured lung, black eye, falls, device malfunction pharmacovigilance comment: sanofi company comment dated 27-dec-2017: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced fracture rib, lung puncture, black eye due to fall, leg weakness, not able to walk, joint range of motion decreased, pain during injection and knee pain and swelling.Although exact event dates are not reported however, based on reported information a temporal relationship cannot be ruled out with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

• Brand Name: SYNVISC ONE
• 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: 7208772
• MDR Text Key: 98193090
• Report Number: 2246315-2018-00045
• 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: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/27/2017

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?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/21/2018
• 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): Hospitalization
• Patient Age: 80 YR