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

GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number CRSP012ZA

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

Patient Problems Injection Site Reaction (4562); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/26/2023

Event Type Injury

Event Description

Fluid was aspirated from the left knee [arthrocentesis].More fluid in the knee [injection site joint effusion] ([condition worsened]).Having increased pain (left knee after 3rd injection) [injection site pain] ([condition aggravated]).Having more swelling (left knee after 3rd injection) [injection site swelling] ([condition aggravated]).Case narrative: initial information received from united states on 26-jan-2023 regarding an unsolicited valid serious case received from a nurse.This case is linked to cases (b)(4) (multiple devices suspect for same patient) and (b)(4) (cluster).This case involves a 72 years old female patient who was having increased pain (left knee after 3rd injection), having more swelling (left knee after 3rd injection), had more fluid in the knee and fluid was aspirated from the left knee, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment included synvisc with 4 times prior to this series.The patient's past medical history, vaccination(s) and family history were not provided.On (b)(6) 2023, the patient received first synvisc injection of the series in right knee.On (b)(6) 2023, the patient received second synvisc injection of the series in right knee.On (b)(6) 2023, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) injection in the left knee (lot: crsp012za, 30-jun-2025) (with unknown strength, dose, route, frequency) for osteoarthritis.Information regarding the batch number and expiry date was not available.On an unknown date jan-2023 after few days the patient was having increased pain (left knee after 3rd injection) (injection site joint pain and condition aggravated), having more swelling (left knee after 3rd injection) (injection site joint swelling, condition aggravated), more fluid in the knee (joint effusion; seriousness criteria: medically significant) and that the aspiration was done after the third injection from the left knee (aspiration joint; seriousness criteria: medically significant).It was reported that the fluid was sent off and was still awaiting culture.Action taken: not applicable for all the events.Corrective treatment: aspiration was done for the event (more fluid in the knee) and not reported for all the events.Outcome: unknown for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 06-feb-2023: this case involves a patient who was having increased pain (right knee after 3rd injection), having more swelling (right knee after 3rd injection), had more fluid in the knee and fluid was aspirated from the right knee, after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.

Event Description

Manufacturer Narrative

Event Description

Fluid was aspirated from the left knee [arthrocentesis] more fluid in the knee [injection site joint effusion] ([condition worsened]) having increased pain (left knee after 3rd injection) [injection site joint pain] ([condition aggravated]) having more swelling (left knee after 3rd injection) [injection site joint swelling] ([condition aggravated]) case narrative: initial information received from united states on 26-jan-2023 regarding an unsolicited valid serious case received from a nurse.This case is linked to cases (b)(4)(multiple devices suspect for same patient) and (b)(4)(cluster).This case involves a 72 years old female patient who was having increased pain (left knee after 3rd injection), having more swelling (left knee after 3rd injection), had more fluid in the knee and fluid was aspirated from the left knee, with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6)2023, the patient received first synvisc injection of the series in right knee.On (b)(6)2023, the patient received second synvisc injection of the series in right knee.On (b)(6)2023, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) injection in the left knee (lot - crsp012za,expiry date: 30-jun-2025) at a strength: 16 mg/2 ml (with unknown dose, route, frequency) for osteoarthritis.Information regarding the batch number and expiry date was not available.On an unknown date (b)(6)2023 after few days the patient was having increased pain (left knee after 3rd injection) (injection site joint pain and condition aggravated), having more swelling (left knee after 3rd injection) (injection site joint swelling, condition aggravated), more fluid in the knee (joint effusion; seriousness criteria: medically significant) and that the aspiration was done after the third injection from the left knee (aspiration joint; seriousness criteria: medically significant).It was reported that the fluid was sent off and was still awaiting culture.Relevant laboratory test results included: aspiration joint - in (b)(6)2023: [still awaiting culture] action taken: not applicable for all the events corrective treatment: aspiration was done for the event (more fluid in the knee) and not reported for rest all the events.Outcome: unknown for all the events.A product technical complaint (ptc) was initiated on 26-jan-2023 for synvisc (lot/batch number: crsp012za expiration date: 30-jun-2025) with global ptc number: (b)(6) based on the complaint from intake team, there is no quality related defect that would pose as a malfunction.Batch # crsp012za, synvisc was manufactured on 22jul2022 with expiration date of 30jun2025 yielding 5,201 kits.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.There were no in process issues noted for plungers during the process.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 nonconforming material or product process.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Customer sample was not available.Root cause could not be determined.Trend analysis: this was the 12th complaint for (b)(4).There were a total of 13 complaints for mother lot crsp012z and sub-batches.100283971 secondary packaging missing unit 100293779 device leakage nos 100297040 hurting injection site / injection site inflammation 100297042 hurting injection site / injection site inflammation 100297044 hurting injection site / injection site inflammation 100297045 hurting injection site / injection site inflammation 100297046 hurting injection site / injection site inflammation 100297047 hurting injection site / injection site inflammation 100297048 hurting injection site / injection site inflammation 100297049 hurting injection site / injection site inflammation 100297050 hurting injection site / injection site inflammation 100297051 hurting injection site / injection site inflammation 100297999 syringe tip broken based on investigation, no capa required.Based on the complaint from intake team, there was no quality related defect that would attribute to a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without product lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events and perform trend analysis on a periodic basis as per to determine if a capa (corrective and preventive action) was required.The final investigation was completed on 03-mar-2023 with summarized conclusion as no assessment possible.Additional information was received on 26-jan-2023 from quality department.Strength and ptc details added.Text amended accordingly.Additional information received on 03-mar-2023 from quality department.Ptc results added.Text amended accordingly.

Event Description

Fluid was aspirated from the left knee/ 45 cc's of fluid build up on her knee [arthrocentesis] more fluid in the knee/ 45 cc's of fluid build up on her knee [injection site joint effusion] ([injection site joint swelling], [injection site joint redness], [condition worsened], [injection site joint pain]) back were achy and sore [back ache] right arm, back, and leg were achy and sore [pain in extremity] felt her bones were aching [bone pain] case narrative: initial information received from united states on 26-jan-2023 regarding an unsolicited valid serious case received from a nurse.This case is linked to cases (b)(4) (multiple devices suspect for same patient) and (b)(4) (cluster) and (b)(4) (duplicate).This case involves 72 years old female patient who developed more fluid in the knee/ 45 cc's of fluid build up on her knee, fluid was aspirated from the left knee/ 45 cc's of fluid build up on her knee, right arm, back, and leg were achy and sore and felt her bones were aching while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, vaccination(s) and family history were not provided.The patient's past medical treatment included synvisc with 4 times prior to this series.On (b)(6) 2023, the patient received first synvisc injection of the series in left knee.On (b)(6) 2023, the patient received second synvisc injection of the series in left knee.On (b)(6) 2023, the patient received third synvisc (hylan g-f 20, sodium hyaluronate) injection in the left knee (lot - crsp012za,expiry date: 30-jun-2025) at a strength: 16 mg/2 ml via intra-articular route (with unknown dose, frequency) for osteoarthritis.On (b)(6) 2023 after same day latency the patient was having increased pain (injection site joint pain), having more swelling (injection site joint swelling), more fluid in the knee (injection site joint effusion) and that the aspiration was done after the third injection from the left knee (aspiration joint).It was reported that the fluid was sent off and was still awaiting culture.The patient experienced severe/ lot of pain (injection site joint pain) more redness (injection site joint erythema) (condition aggravated) and swelling with 45 cc's of fluid buildup on her knee (injection site joint effusion), she stated that her right arm, back, and leg were achy and sore (pain in extremity) (back pain).She received a series of three injections and the adverse events gradually increased.The doctor provided her with pain killers that were stronger than the ibuprofen she was previously taking and also administered a cortisone shot.The physician explained that the product could be a bad lot number.Symptoms were still present but gradually improving.Patient did not have lot number and expiration date but stated that she believed her provider already reported a possible bad lot number due to seeing this problem in several patients.Patient suspected a bad batch of the product.Patient stated that it felt her bones were aching.(bone pain).It was unknown if the patient experienced any additional symptoms/ events.Action taken: not applicable for all the events corrective treatment: aspiration was done for the event (more fluid in the knee) and painkillers and cortisone shots, ibuprofen was received for rest of the events.Outcome: recovering for all the events.Seriousness criteria: medically significant from aspiration joint, injection site joint effusion.A product technical complaint (ptc) was initiated on 26-jan-2023 for synvisc (lot/batch number: crsp012za expiration date: 30-jun-2025) with global ptc number: 100297051 the sample status of the ptc was not received and the ptc stated: based on the complaint from intake team, there is no quality related defect that would pose as a malfunction.Batch # crsp012za, synvisc was manufactured on 22jul2022 with expiration date of 30jun2025 yielding 5,201 kits.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.There were no in process issues noted for plungers during the process.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 nonconforming material or product process.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Customer sample was not available.Root cause could not be determined.Trend analysis: this was the 12th complaint for crsp012za.There were a total of 13 complaints for mother lot crsp012z and sub-batches.1(b)(4) secondary packaging missing unit (b)(4) device leakage nos (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) hurting injection site / injection site inflammation (b)(4) syringe tip broken based on investigation, no capa required.Based on the complaint from intake team, there was no quality related defect that would attribute to a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without product lot numbers, and assesses possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events and perform trend analysis on a periodic basis as per to determine if a capa (corrective and preventive action) was required.The final investigation was completed on 03-mar-2023 with summarized conclusion as no assessment possible.Additional information was received on 26-jan-2023 from quality department.Strength and ptc details added.Text amended accordingly.Additional information received on 03-mar-2023 from quality department.Ptc results added.Text amended accordingly.Upon internal review on 02-jun-2023, all the information from the case (b)(4) (with csd of (b)(6) 2023, (b)(6) 2023) (to be deleted) has been merged in case (b)(4).The events of bone pain, pain in extremity, back pain and injection site joint erythema were added.Corrective treatment was added.Therapy dates was updated.Text amended accordingly.

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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

bridgewater 08807

MDR Report Key

16305617

MDR Text Key

308871322

Report Number

2246315-2023-00010

Device Sequence Number

Product Code

MOZ

Combination Product (y/n)

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Health Professional

Reporter Occupation

Other Health Care Professional

Type of Report

Initial,Followup,Followup,Followup

Report Date

06/21/2023

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?

Device Lot Number

CRSP012ZA

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Yes

Initial Date Manufacturer Received

Not provided

Initial Date FDA Received

02/06/2023

Supplement Dates Manufacturer Received

Not provided
Not provided
Not provided

Supplement Dates FDA Received

02/14/2023
03/09/2023
06/21/2023

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?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention; Other;

Patient Age

72 YR

Patient Sex

Female

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

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