MAUDE Adverse Event Report: SYNVISC; MOZ

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

Patient Problems Muscle Weakness (1967); Loss of Range of Motion (2032); Therapeutic Response, Decreased (2271); Arthralgia (2355); No Code Available (3191)

Event Type  Injury  

Event Description

Pain has recurred/tenderness at the lateral joint space or line and pain with mcmurray's testing [aching (l) knee] ([subtherapeutic response]), knee replacement on the contralateral side [partial knee replacement], knock-knee deformity/left knee valgus deformity, acquired [knock-knee], loss of her lateral joint space [joint space narrowing], mild sclerosis, left hip [arthrosclerosis], lacks about 5 degrees from terminal extension in left knee [joint range of motion decreased], significant tenderness at the trochanteric bursa region/left hip trochanteric bursitis [trochanteric bursitis], leg is going to give out on her [lower extremities weakness of], left hip pain/throbbing and aching lateral-based left hip pain ranging from 4 to 6/10/worse with prolonged walking and moving the leg [pain in hip] ([pain upon movement]), injection administered by intramuscular route [incorrect route of product administration].Case narrative: initial information received on 26-jun-2019 regarding a solicited valid serious case from a physician, in the scope of patient support program "(b)(6)".Patient id: (b)(6); country: united states.Study title: (b)(6).This case involves a (b)(6) female patient who experienced pain has recurred/tenderness at the lateral joint space or line and pain with mcmurray's testing, knock-knee deformity/left knee valgus deformity, acquired, lacks about 5 degrees from terminal extension in left knee, significant tenderness at the trochanteric bursa region/left hip trochanteric bursitis, loss of her lateral joint space, mild sclerosis, left hip, leg is going to give out on her, knee replacement on the contralateral side, left hip pain/throbbing and aching lateral-based left hip pain ranging from 4 to 6/10/worse with prolonged walking and moving the leg and injection administered by intramuscular route (latency: unknown), while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included osteoarthritis.The patient's past medical treatment, vaccination(s) and family history were not provided.On (b)(6) 2018, the patient received injection via intramuscular route at unknown dosage once (batch number: unknown) for osteoarthritis of knee.Information on batch number was requested.On (b)(6) 2019, patient visited hospital for follow-up on left knee.Patient was in no acute distress, alert and oriented to person and place; mood appropriate with unlabored respirations and regular rate and rhythm.Patient had no skin abrasions/rashes.As of unknown date, patient reported that her previous injection into the left knee with visco-supplementation did not provide near as much relief as the one prior to this and the pain recurred.As of unknown date, patient had a complaint of lateral-based left hip pain.Patient was unsure if these were related.As of unknown date, patient rated her pain as ranging from 4 to 6/10, throbbing and aching in nature, worsened with prolonged walking and moving the leg.On an unknown date, patient also noticed a bit of knock-knee deformity which was relieved by rest and laying down.On an unknown date, she felt as though the leg was going to give out on her.On an unknown date, patient had knee replacement on the contralateral side but was hopeful to avoid surgical intervention at this time if possible (assessed as medically significant).Patient denied any numbness or tingling.On (b)(6) 2019, the musculoskeletal examination of left lower extremity revealed a valgus deformity to the left knee that was not completely correctable.As of unknown date, patient had tenderness at the lateral joint space, lacked about 5 degrees from terminal extension and flexion to 120 degrees.Patient had pain with mcmurray's testing (assessed as serious- intervention required).On (b)(6) 2019, hip examination showed smooth range of motion and no pain but significant tenderness at the trochanteric bursa region.Imaging results for hip showed preserved joint space with some mild sclerosis and no evidence of fracture or dislocation.On (b)(6) 2019, left knee imaging results showed complete loss of lateral joint space and valgus deformity with rim osteophyte formation but no fractures.Final assessment included left knee end-stage osteoarthritis, left knee valgus deformity, acquired and left hip trochanteric bursitis.Action taken: not applicable.Corrective treatment: triamcinolone acetonide (kenalog) for pain has recurred/tenderness at the lateral joint space or line and pain with mcmurray's testing.Outcome: unknown for all events.A product technical compliant was initiated and results were pending for the same.Reporter causality: unassessable for all events.Company causality: not reportable for all events.

Event Description

Pain has recurred/tenderness at the lateral joint space or line and pain with mcmurray's testing [aching (l) knee] ([subtherapeutic response]) knee repalcement on the contralateral side [partial knee replacement] knock-knee deformity/left knee valgus deformity, acquired [knock-knee] loss of her lateral joint space [joint space narrowing] mild sclerosis, left hip [arthrosclerosis] lacks about 5 degrees from terminal extension in left knee [joint range of motion decreased] significant tenderness at the trochanteric bursa region/left hip trochanteric bursitis [trochanteric bursitis] leg is going to give out on her [lower extremities weakness of] left hip pain/throbbing and aching lateral-based left hip pain ranging from 4 to 6/10/worse with prolonged walking and moving the leg [pain in hip] ([pain upon movement]) injection administered by intramuscular route [incorrect route of product administration] case narrative: initial information received on 26-jun-2019 regarding a solicited valid serious case from a physician, in the scope of patient support program "psp_saus.Tjo.012".Patient id: (b)(6) country: united states study title: sanofi patient connection.This case involves a 73 years old female patient who experienced pain has recurred/tenderness at the lateral joint space or line and pain with mcmurray's testing, knock-knee deformity/left knee valgus deformity, acquired, lacks about 5 degrees from terminal extension in left knee, significant tenderness at the trochanteric bursa region/left hip trochanteric bursitis, loss of her lateral joint space, mild sclerosis, left hip, leg is going to give out on her, knee replacement on the contralateral side, left hip pain/throbbing and aching lateral-based left hip pain ranging from 4 to 6/10/worse with prolonged walking and moving the leg and injection administered by intramuscular route (latency: unknown), while she was treated with hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included osteoarthritis.The patient's past medical treatment, vaccination(s) and family history were not provided.On (b)(6) 2018, the patient received injection via intramuscular route at unknown dosage once (batch number: unknown) for osteoarthritis of knee.Information on batch number was requested.On (b)(6) 2019, patient visited hospital for follow-up on left knee.Patient was in no acute distress, alert and oriented to person and place; mood appropriate with unlabored respirations and regular rate and rhythm.Patient had no skin abrasions/rashes.As of unknown date, patient reported that her previous injection into the left knee with viscosupplementation did not provide near as much relief as the one prior to this and the pain recurred.As of unknown date, patient had a complaint of lateral-based left hip pain.Patient was unsure if these were related.As of unknown date, patient rated her pain as ranging from 4 to 6/10, throbbing and aching in nature, worsened with prolonged walking and moving the leg.On an unknown date, patient also noticed a bit of knock-knee deformity which was relieved by rest and laying down.On an unknow date, she felt as though the leg was going to give out on her.On an unknown date, patient had knee replacement on the contralateral side but was hopeful to avoid surgical intervention at this time if possible (assessed as medically significant).Patient denied any numbness or tingling.On (b)(6) 2019, the musculoskeletal examination of left lower extremity revealed a valgus deformity to the left knee that was not completely correctable.As of unknown date, patient had tenderness at the lateral joint space, lacked about 5 degrees from terminal extension and flexion to 120 degrees.Patient had pain with mcmurray's testing (assessed as serious- intervention required).On (b)(6) 2019, hip examination showed smooth range of motion and no pain but significant tenderness at the trochanteric bursa region.Imaging results for hip showed preserved joint space with some mild sclerosis and no evidence of fracture or dislocation.On (b)(6) 2019, left knee imaging results showed complete loss of lateral joint space and valgus deformity with rim osteophyte formation but no fractures.Final assessment included left knee end-stage osteoarthritis, left knee valgus deformity, acquired and left hip trochanteric bursitis.Action taken: not applicable.Corrective treatment: triamcinolone acetonide (kenalog) for pain has recurred/tenderness at the lateral joint space or line and pain with mcmurray's testing.Outcome: unknown for all events a product technical complaint was initiated on (b)(6) 2019 for synvisc-one.Batch number: unknown global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformation 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Final investigation complete date: 16-jul-2019.Reporter causality: unassessable for all events.Company causality: not reportable for all events.Additional information received on 16-jul-2019.Investigation summary received and ptc results added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• MDR Report Key: 8764135
• MDR Text Key: 150127941
• Report Number: 2246315-2019-00189
• 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,study
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 99