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

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

Patient Problems Erythema (1840); Pain (1994); Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191)

Event Date 02/12/2020

Event Type  Injury  

Event Description

In right knee she was able to only get three quarters because it was so painful and she was not able to take it any longer/had to stop during injection on right leg [pain during injection] ([incomplete dose administered]).Shin bone is very sore/shin bone is sore to touch [tibia pain].On the side of her knee going down her leg the tendon is painful [tendon pain].On the side of her knee going down her leg the tendon is painful/on the right side of her leg is very sore/sore all over from the knee down/it is getting worse now because it is in both legs [leg pain] ([condition worsened]).Can hardly stand up anymore [difficulty in standing].It only gets red if it is rubbed but, she does have some swelling/ redness and swelling around the knees [localised erythema].When going from the couch to the bathroom it is hard to walk [walking difficulty].Three fingers down from the inside of the knee is a pocket of fluid [lower leg edema].It only gets red if it is rubbed but, she does have some swelling/ redness and swelling around the knees [swelling of r knee].Feels like her knee and joint is stiffening up and its hard [joint stiffness].On the side of her knee going down her leg the tendon is painful/sore all over from the knee down [aching (r) knee].Case narrative: this case is linked to case (b)(4) (same patient, multiple devices, left knee).Initial information was received from united states on 20-apr-2020 regarding an unsolicited valid serious case from a patient via phone.This case involves a (b)(6) years old female patient who received medical device hylan g-f 20, sodium hyaluronate [synvisc one] in right knee and reported that in right knee she was able to only get three quarters because it was so painful and she was not able to take it any longer/had to stop during injection on right leg (pain during injection); shin bone is very sore/shin bone is sore to touch; on the side of her knee going down her leg the tendon is painful/on the right side of her leg is very sore/sore all over from the knee down/it is getting worse now because it is in both legs (pain in extremity); can hardly stand up anymore; it only gets red if it is rubbed but, she does have some swelling/ redness and swelling around the knees; when going from the couch to the bathroom it is hard to walk; three fingers down from the inside of the knee is a pocket of fluid; feels like her knee and joint is stiffening up and its hard; on the side of her knee going down her leg the tendon is painful/sore all over from the knee down (aching (r) knee); on the side of her knee going down her leg the tendon is painful (tendon pain).The patient's past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.At the time of the event, the patient had ongoing chronic obstructive pulmonary disease (copd).On (b)(6) 2020 (about 10 weeks ago), the patient received synvisc one (hylan g-f 20, sodium hyaluronate) injection once in right knee (dose and lot - unknown) for arthritis.In the context of covid19 crisis, the batch number and expiration date were not requested.On same day of receiving injection, the patient had to stop during injection on right leg.In the right knee she was able to only get three quarters because it was so painful, and she was not able to take it any longer (latency: same day caused disability).After the injection, she had to get a wheelchair and be wheeled out to the car.Patient stated that she was sore for a while.Since an unknown date in 2020, few weeks after the injection, on the side of her right knee going down her leg the tendon was painful, and it was hard for her to walk (latency: few weeks).Her shin bone and on the right side of her leg was very sore (latency: few weeks).When going from the couch to the bathroom it was hard to walk.She did not have a fever.The patient felt like her knee and joint is stiffening up and its hard (latency: few weeks).As per patient, her knee only got red if it was rubbed but, she did have some swelling.Reportedly, three fingers down from the inside of the knee was a pocket of fluid (latency: few weeks).The patient stated that she was sore all over from the knee down and her shin bone was sore to touch.She could hardly stand up anymore (latency: few weeks).Instead of getting better she was getting worse.There was now redness and swelling around the knees.She stated that she had to take vicodin on (b)(6) 2020 (today) for the pain and it was getting worse now because it was in both legs.Action taken: not applicable for all the events.Corrective treatment: wheelchair for in right knee she was able to only get three quarters because it was so painful and she was not able to take it any longer/had to stop during injection on right leg; hydrocodone bitartrate, paracetamol (vicodin) for aching (r) knee, pain in extremity, shin bone is very sore/shin bone is sore to touch and tendon pain; not reported for rest all events.Outcome: unknown for in right knee she was able to only get three quarters because it was so painful, and she was not able to take it any longer/had to stop during injection on right leg; not recovered / not resolved for rest all events.A pharmaceutical technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc one, batch number: unknown 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.Final investigation was completed on 29-apr-2020.Follow up information received on 20-apr-2020 from healthcare professional.Global ptc number added.Follow up information received on 20-apr-2020 from healthcare professional.Global ptc number was updated.Additional information was received on 29-apr-2020 from health care professional.Ptc results were added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 10033284
• MDR Text Key: 196834637
• Report Number: 2246315-2020-00060
• 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: health professional
• Type of Report: Initial
• Report Date: 05/06/2020

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: 05/07/2020
• 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