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

Lot Number UNKNOWN

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

Patient Problems Unspecified Infection (1930); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2021

Event Type  Injury  

Event Description

It was infected after taking potential counterfeit of synvisc one [joint infection].([swelling of l knee], [arthralgia aggravated]).Not having been able to work [impaired work ability].Case narrative: initial information received on 13-aug-2021 regarding an unsolicited valid serious case received from a pharmacist from (b)(6).This case involves an unknown age female patient whose knee was infected after taking hylan g-f 20, sodium hyaluronate [synvisc one] and she had not been able to work.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) once (strength: 48 mg/ 6 ml) (lot, dose, route, indication: unknown) in left knee.On (b)(6) 2021 after a latency of 6 days patient's left injected knee got all swollen and painful (arthralgia and joint swelling; seriousness: hospitalization, intervention required and medically significant).Patient fortunate to have been able to see orthopaedic surgeon who put her on tremadol slow release as well as oxycodone hydrochloride (endone) pain tablets which eased the pain for 8 days.On (b)(6) 2021 patient checked into hospital emergency department because the pain had got so unbearable and blood tests were done.The patient was admitted to the hospital on (b)(6) 2021 where patient had surgery to the knee (arthroscopic wash out) as it was infected (arthritis infective; onset: (b)(6) 2021; latency: few days; seriousness: hospitalization, intervention required and medically significant).This left the patient with so much pain and loss of income from not having been able to work (impaired work ability; onset: 2021; latency: few days; seriousness: disability).Patient would return the unused hylan g-f 20, sodium hyaluronate and would like to claim money back from the pharmacy for the one that had been used.The patient believe it was a bad batch which caused so much pain with time spent in hospital.Action taken: not applicable for both events.The patient was treated with tramadol, oxycodone hydrochloride (endone) and had an arthroscopic washout for the arthralgia associated with arthritis infective; treatment not reported for impaired work ability.At time of reporting, the outcome was unknown for the event it was infected and not having been able to work.Product technical complaint (ptc) was initiated with global ptc number 100149428 on 13-aug-2021 for product.Batch number; unknown; sample status: requested & awaited the investigation was in process.

Event Description

It was infected after taking synvisc one [joint infection] ([swelling of l knee], [arthralgia aggravated]).Not having been able to work [impaired work ability].Case narrative: initial information received on 13-aug-2021 regarding an unsolicited valid serious case received from a pharmacist from australia.This case involves an unknown age female patient whose knee was infected after taking hylan g-f 20, sodium hyaluronate [synvisc one] and she had not been able to work.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) once (strength: 48 mg/ 6 ml) (lot, dose, route, indication: unknown) in left knee.On (b)(6) 2021 after a latency of 6 days patient's left injected knee got all swollen and painful (arthralgia and joint swelling; seriousness: hospitalization, intervention required and medically significant).Patient fortunate to have been able to see orthopaedic surgeon who put her on tremadol slow release as well as oxycodone hydrochloride (endone) pain tablets which eased the pain for 8 days.On (b)(6)2021 patient checked into hospital emergency department because the pain had got so unbearable and blood tests were done.The patient was admitted to the hospital on (b)(6) 2021 where patient had surgery to the knee (arthroscopic wash out) as it was infected (arthritis infective; onset: (b)(6) 2021; latency: few days; seriousness: hospitalization, intervention required and medically significant).This left the patient with so much pain and loss of income from not having been able to work (impaired work ability; onset: 2021; latency: few days; seriousness: disability).Reportedly, the pharmacist had purchased 2 synvisc one gels last year and had them injected into both his knees by with no issues and that year had purchased two more synvisc one gels on (b)(6) 2021 and had the first knee (left knee) injected on (b)(6) 2021.The second appointment was cancelled due to what had happened.Patient would return the unused hylan g-f 20, sodium hyaluronate and would like to claim money back from the pharmacy for the one that had been used.The patient believe it was a bad batch which caused so much pain with time spent in hospital.Action taken: not applicable for both events.The patient was treated with tramadol, oxycodone hydrochloride (endone) and had an arthroscopic washout for the arthralgia associated with arthritis infective; treatment not reported for impaired work ability.At time of reporting, the outcome was unknown for the event it was infected and not having been able to work.A product technical complaint (ptc) was initiated on 13-aug-2021 for product (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 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 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 24-aug-2021 with conclusion summarized as no assessment possible.Additional information was received on 24-aug-2021 from other healthcare professional.Ptc results received and processed.Text amended accordingly.

Event Description

It was infected after taking synvisc one [joint infection] ([injection site joint redness], [stiff knees], [injection site joint warmth], [c-reactive protein increased], [swelling of l knee], [arthralgia aggravated], [joint range of motion decreased], [synovitis]) can't walk without a walking stick [unable to walk].Not having been able to work [impaired work ability].Case narrative: initial information received on 13-aug-2021 regarding an unsolicited valid serious case received from a pharmacist from australia.This case involves an unknown age female patient whose knee was infected, can't walk without a walking stick and not having been able to work, after taking hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history included hip arthroplasty in jun-2021.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing type 1 diabetes mellitus, arthropathy and meniscus injury.On 23-jul-2021, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) once (strength: 48 mg/ 6 ml) (lot, dose, route, indication: unknown) in left knee.On 29-jul-2021 after a latency of 6 days patient's left injected knee got all swollen and painful (arthralgia and joint swelling; seriousness: hospitalization, intervention required and medically significant).Patient fortunate to have been able to see orthopaedic surgeon who put her on tremadol slow release as well as oxycodone hydrochloride (endone) pain tablets which eased the pain for 8 days.The pain settled a bit but on 08-aug-2021 patient checked into hospital emergency department because the pain had got so unbearable (it had reached a number 10).Knee was red (injection site joint erythema; onset: 08-sep-2021; latency: 1 month 16 days; seriousness: hospitalization, intervention required and medically significant), knee was warm (injection site joint warmth; onset: 2021; latency: few days; seriousness: hospitalization, intervention required and medically significant), had an active range of movement of 5-110 (joint range of motion decreased; onset: 2021; latency: few days; seriousness: hospitalization, intervention required and medically significant) and swollen.Blood tests were done while the patient was in emergency room.The patient was admitted to the hospital on 09-aug-2021 where patient had surgery to the knee (arthroscopic synovectomy; aspirated 2400 10x6 white blood cells with 100% neutrophils, negative gram strain and culture) as it was infected (arthritis infective; onset: aug-2021; latency: few days; seriousness: hospitalization, intervention required and medically significant).During the arthroscopy, the synovial fluid was clear and the joint was not seen to be overtly infected with patchy synovitis (synovitis; onset: 2021; latency: few days; seriousness: hospitalization, intervention required and medically significant).This left the patient with so much pain and loss of income from not having been able to work (impaired work ability; onset: 2021; latency: few days).Patient was given cefazolin after arthroscopic synovectomy and was advised regarding full weightbearing, full range of motion and leave the dressing undisturbed for 12 days.Reportedly, the patient had purchased two synvisc one gels for both the knees but the second appointment was cancelled due to what had happened.Patient would return the unused hylan g-f 20, sodium hyaluronate and would like to claim money back from the pharmacy for the one that had been used.The patient believed it was a bad batch which caused so much pain with time spent in hospital.Since an unknown date in 2021, after unknown latency, patient could not walk without a walking stick (gait inability; seriousness: disability).Patient was still in pain as of 10-sep-2021 and was attending physio to get movement.Action taken: not applicable for all events the patient was treated with tramadol, oxycodone hydrochloride (endone) and had an arthroscopic washout for the arthralgia after which cefazolin was given associated with arthritis infective; treatment not reported for impaired work ability at time of reporting, the outcome was unknown for all events.A product technical complaint (ptc) was initiated on 13-aug-2021 for product (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 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 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 24-aug-2021 with conclusion summarized as no assessment possible.Additional information was received on 24-aug-2021 from other healthcare professional.Ptc results received and processed.Text amended accordingly.Additional information received on 10-sep-2021 from the patient.Symptoms of joint range of motion decreased, injection site joint warmth, injection site joint erythema, synovitis were added.Event of gait inability added.Medical history was added.Clinical course updated and text amended accordingly.Based on the information previously received,annex e code updated from blank to e1906.Text 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: 12347234
• MDR Text Key: 267421934
• Report Number: 2246315-2021-00139
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• 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): Hospitalization; Disability; Required Intervention; Other
• Patient Sex: Female