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

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Septic arthritis with rapid progressive destruction of the femoral head (left side hip) septic arthritis.Immobile, subluxation hip, fever, reduced general condition, osteolysis, osteonecrosis, bone loss, pain in hip.Case narrative: initial information received on 24-may-2023 via health care professional from germany regarding an unsolicited valid serious case issued from a literature article.Freigang v, baumann f, alt v.Bilateral septic arthritis with rapid progressive destruction of the femoral head after joint injection in rheumatoid arthritis.J bone joint infect.2021 ;6(7) :255-6.Available from: https://doi.Org/10.5194/jbji-6-255-2021.This case is linked to (b)(4) (same patient, multiple device use).This case involves a 61 years old and unknown gender patient who experienced septic arthritis with rapid progressive destruction of the femoral head (left side hip) while being treated with the use of medical device hylan g f 20, sodium hyaluronate [synvisc] (latency: unknown).The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient with steroid therapy for rheumatoid arthritis and had pain in the groin on both sides (concurrent condition).On an unknown date, twelve weeks before the first consultation in institution, an orthopedic surgeon revealed the diagnosis of advanced osteoarthritis of the hip on both sides (concurrent condition) and injected hyaluronic acid of dosage form solution for injection via route intraarticular (dose, strength, frequency, batch number/lot number, expiry date: unspecified) in left side hip joint.Subsequently, the pain increased (arthralgia), leading to immobility (immobile) and poor general condition (general physical health deterioration).Twelve weeks after the injection, the patient presented to emergency department with fever (pyrexia), reduced general condition and pain in left side hip.On admission, the patient's c-reactive protein level (crp) level was 371 mg/l and the white blood cell (wbc) count was 17.3 per nanolitre.The x-ray of the pelvis shows rapid progressive destruction of left side hip joint/femoral head necrosis on left side hip with extensive osteolysis (osteonecrosis) (osteolysis), a subluxation (joint dislocation) and an acetabular bony defect of the left side/bone loss (bone loss).The patient was diagnosed with septic arthritis with rapid progressive destruction of the femoral head (left side hip) (arthritis bacterial).The patient received emergent surgical debridement of left side hip joint and implantation of antibiotic-coated articular spacers.After treatment of the infection with repeated debridement and spacer exchange, implanted a silver-coated non cemented standard prosthesis on left side hip.The author reported a clinical case of rapid progressive destruction of the femoral head caused by infection after joint injection in rheumatoid arthritis.Further, recommend a strict risk-benefit analysis before intraarticular application of hyaluronic acid in patients with rheumatoid arthritis and long-term steroid therapy.Action taken: not applicable.Corrective treatment: emergent surgical debridement of left side hip joint and implantation of antibiotic-coated articular spacers, repeated debridement and spacer exchange, implanted a silver-coated non cemented standard prosthesis on left side hip outcome: recovering/resolving.Seriousness criteria: medically significant, hospitalization and disability.Reporter causality: related.A significant amendment has been performed with receipt date (b)(6) 2023: to add the brand name of suspect drug as synvisc (no hyaluronic acid visco-supplement brand name was reported in the article publication.The company tried to obtain an answer from the author and the mails sent on 05-jun-2023, 05-jul-2023 remained unanswered.Hence, it is captured under synvisc in a conservative approach).

Event Description

Septic arthritis with rapid progressive destruction of the femoral head (left side hip) [septic arthritis] ([immobile], [subluxation hip], [fever], [reduced general condition], [osteolysis], [osteonecrosis], [bone loss], [pain in hip]).Case narrative: initial information received on 24-may-2023 via health care professional from germany regarding an unsolicited valid serious case issued from a literature article freigang v, baumann f, alt v.Bilateral septic arthritis with rapid progressive destruction of the femoral head after joint injection in rheumatoid arthritis.J bone joint infect.2021 ;6(7) :255-6.Available from: https://doi.Org/10.5194/jbji-6-255-2021.This case is linked to (b)(6) (same patient, multiple device use).This case involves a 61 years old and unknown gender patient who experienced septic arthritis with rapid progressive destruction of the femoral head (left side hip) while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) or (synvisc one) (latency: unknown).The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient with steroid therapy for rheumatoid arthritis and had pain in the groin on both sides (concurrent condition).On an unknown date, twelve weeks before the first consultation in institution, an orthopedic surgeon revealed the diagnosis of advanced osteoarthritis of the hip on both sides (concurrent condition) and injected hyaluronic acid of dosage form solution for injection via route intraarticular (dose, strength, frequency, batch number/lot number, expiry date: unspecified) in left side hip joint.Subsequently, the pain increased (arthralgia), leading to immobility (immobile) and poor general condition (general physical health deterioration).Twelve weeks after the injection, the patient presented to emergency department with fever (pyrexia), reduced general condition and pain in left side hip.On admission, the patient's c-reactive protein level (crp) level was 371 mg/l and the white blood cell (wbc) count was 17.3 per nanolitre.The x-ray of the pelvis shows rapid progressive destruction of left side hip joint/femoral head necrosis on left side hip with extensive osteolysis (osteonecrosis) (osteolysis), a subluxation (joint dislocation) and an acetabular bony defect of the left side/bone loss (bone loss).The patient was diagnosed with septic arthritis with rapid progressive destruction of the femoral head (left side hip) (arthritis bacterial).The patient received emergent surgical debridement of left side hip joint and implantation of antibiotic-coated articular spacers.After treatment of the infection with repeated debridement and spacer exchange, implanted a silver-coated non cemented standard prosthesis on left side hip.The author reported a clinical case of rapid progressive destruction of the femoral head caused by infection after joint injection in rheumatoid arthritis.Further, recommend a strict risk-benefit analysis before intraarticular application of hyaluronic acid in patients with rheumatoid arthritis and long-term steroid therapy.Action taken: not applicable.Corrective treatment: emergent surgical debridement of left side hip joint and implantation of antibiotic-coated articular spacers, repeated debridement and spacer exchange, implanted a silver-coated non cemented standard prosthesis on left side hip outcome: recovering/resolving.Seriousness criteria: medically significant, hospitalization and disability.Reporter causality: related.A significant amendment has been performed with receipt date 24-may-2023: to add the brand name of suspect drug as synvisc in the product tab (no hyaluronic acid visco-supplement brand name was reported in the article publication.The company tried to obtain an answer from the author and the mails sent on 05-jun-2023, 05-jul-2023 remained unanswered.Hence, it is captured under synvisc in product tab and synvisc or synvisc one brands in narrative in a conservative approach).A product technical complaint (ptc) was initiated on 25-may-2023 for synvisc (lot/batch number: unknown) with global ptc number: 100348445.The sample status of the ptc was not available.The ptc stated, preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no corrective and preventive action (capa) is required.It is 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 non-conformance report (ncr) process.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 21-aug-2023 with summarized conclusion as no assessment possible.Additional information was received on 02-aug-2023 via other health care professional from quality department: ptc details were added.Text amended accordingly.Additional information was received on 21-sep-2023 via other health care professional from quality department: ptc details were added.Text amended accordingly.

• 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: 17440620
• MDR Text Key: 320205442
• Report Number: 2246315-2023-00083
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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 the Reporter a Health Professional?: Yes
• 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): Required Intervention; Disability; Hospitalization; Other
• Patient Age: 61 YR