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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191); Swelling/ Edema (4577)

Event Date 05/01/2020

Event Type  Injury  

Event Description

Thick/swollen knee, swelling continued up to the ankle in the following days [knee swelling] ([unilateral leg swelling]).Aching knee/did not have such arthrosis pain before [arthralgia aggravated] ([pain upon movement]).Possibly broken baker cyst [baker's cyst ruptured].Assume an intolerance, allergy to synvisc [device intolerance].Assume an intolerance, allergy to synvisc [allergy].Case narrative: initial information received on 08-jun-2020 from (b)(6) regarding an unsolicited valid serious case received from a patient.This case involves a female patient of unknown age who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and experienced thick/swollen knee, swelling continued up to the ankle in the following days; aching knee/did not have such arthrosis pain before; possibly broken baker cyst; assume an intolerance, allergy to synvisc, (latency unknown).The patient's past vaccination(s) and family history were not provided.Patient had a history of getting such an injection (unspecified) a year ago and had similar symptoms.However, the problems only appeared after 3 weeks thus she thought that these were the consequences of a longer journey (long sitting).At the time of the event, the patient had ongoing arthrosis pain.Concomitant medications included ethyl loflazepate (victan) (for 28 years).On an unknown date in (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate once (formulation, dose, route and batch number unknown) for cox-arthrosis.Information on batch number was requested.On an unknown date in (b)(6) 2020, next day after latency of 1 day, patient experienced thick/swollen aching knee, the swelling continued up to the ankle (intervention required) in the following days.The patient treated the problem with the pech method.However, after 10 days the orthopedic surgeon gave the patient tablets of cortisone (20 pieces).On an unknown date in 2020, swelling had now completely disappeared, but still she was in so much pain that she could only walk for a limited short distance with severe pain and climbing stairs upwards was especially painful and she did not have such arthrosis pain before (onset: 2020; latency: unknown).On an unknown date in 2020, after unknown latency, patient assumed an intolerance, allergy to hylan g-f 20, sodium hyaluronate and her orthopedist also told something about a possible broken baker cyst.The patient asked if she had to live with the pain until the drug was broken down, or there were ways to speed up the breakdown.Furthermore, she enquired if the hyaluronic preparation damage her knee even more.Action taken: not applicable for all events.The patient was treated with cortisone for thick/swollen knee, swelling continued up to the ankle, aching knee/did not have such arthrosis pain before; not reported for rest of the events.The patient outcome is reported as recovered / resolved for thick/swollen knee, swelling continued up to the ankle; as not recovered / not resolved for aching knee/did not have such arthrosis pain before; unknown for rest all events.A product technical complaint was initiated and results were pending for the same.

Event Description

Thick/swollen knee, swelling continued up to the ankle in the following days [knee swelling] ([unilateral leg swelling]).Aching knee/did not have such arthrosis pain before [arthralgia aggravated] ([pain upon movement]).Possibly broken baker cyst [baker's cyst ruptured].Assume an intolerance, allergy to synvisc [device intolerance].Assume an intolerance, allergy to synvisc [allergy].Case narrative: initial information received on 08-jun-2020 from germany regarding an unsolicited valid serious case received from a patient.This case involves a female patient of unknown age who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and experienced thick/swollen knee, swelling continued up to the ankle in the following days; aching knee/did not have such arthrosis pain before; possibly broken baker cyst; assume an intolerance, allergy to synvisc, (latency unknown) the patient's past vaccination(s) and family history were not provided.Patient had a history of getting such an injection (unspecified) a year ago and had similar symptoms.However, the problems only appeared after 3 weeks thus she thought that these were the consequences of a longer journey (long sitting).At the time of the event, the patient had ongoing arthrosis pain.Concomitant medications included ethyl loflazepate (victan) (for 28 years).On an unknown date in (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate once (formulation, dose, route and batch number unknown) for cox-arthrosis.Information on batch number was requested.On an unknown date in (b)(6) 2020, next day after latency of 1 day, patient experienced thick/swollen aching knee, the swelling continued up to the ankle (joint swelling and peripheral swelling; intervention required) in the following days.The patient treated the problem with the pech method.However, after 10 days the orthopedic surgeon gave the patient tablets of cortisone (20 pieces).On an unknown date in 2020, swelling had now completely disappeared, but still she was in so much pain that she could only walk for a limited short distance with severe pain and climbing stairs upwards was especially painful and she did not have such arthrosis pain before (arthralgia; pain; onset: 2020; latency: unknown).On an unknown date in 2020, after unknown latency, patient assumed an intolerance (device intolerance), allergy to hylan g-f 20, sodium hyaluronate (hypersensitivity) and her orthopedist also told something about a possible broken baker cyst (synovial rupture).The patient asked if she had to live with the pain until the drug was broken down, or there were ways to speed up the breakdown.Furthermore, she enquired if the hyaluronic preparation damage her knee even more.Action taken: not applicable for all events.Corrective treatment: cortisone for joint swelling, peripheral swelling, arthralgia; not reported for rest of the events.Outcome: recovered / resolved for joint swelling, peripheral swelling; not recovered / not resolved for arthralgia; unknown for rest all events.A product technical complaint (ptc) was initiated on 08-jun-2020 for synvisc for unknown batch number and global ptc number: 100103313.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 is identified and mitigated through the ncr process.Sanofi 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 has not indicated any safety issue.Sanofi will continue to monitor complaints to determine if a capa is required.Final investigation was completed on 25-feb-2021.Additional information was received on 08-jun-2020 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on 25-feb-2021 from other healthcare professional.Ptc results received and processed.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10168134
• MDR Text Key: 201193068
• Report Number: 2246315-2020-00072
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VICTAN (ETHYL LOFLAZEPATE),UNKNOWN; VICTAN (ETHYL LOFLAZEPATE),UNKNOWN
• Patient Outcome(s): Required Intervention