MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RLS021

Device Problems Device Contamination With Biological Material (2908); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Joint Swelling (2356); Loss of consciousness (2418); No Code Available (3191)

Event Date 11/09/2017

Event Type malfunction

Event Description

This case was cross referenced with 2017sa234633 (same patient).This unsolicited case from united states was received on(b)(6) 2017 from the non-health care professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after unknown latency the patient experienced decrease mobility, inability to bear weight, pain and severe swelling.No relevant medical history, past medications and concomitant medications were reported.On (b)(6)2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 6 ml once (lot number: 7rls021 and expiration date: 31- may-2020) for osteoarthritis (oa) knee pain in the suprapatellar pouch of the left knee.On an unknown date in (b)(6) 2017, unknown latency of receiving the injection the patient experienced severe swelling, pain, decrease mobility, inability to bear weight.It was reported that the patient received bilateral injections on different days.Corrective treatment: unspecified for all the events.Outcome: recovering for all the events.Seriousness criterion: required intervention for all the events a pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Pharmacovigilance comment: sanofi company comment dated 24-nov-2017: this case concerns a female patient who received treatment with synvisc one and later suffered from mobility decreased and weight bearing difficulty.Based on the available information, pharmacological plausibility can be established between the events and suspect product.However, further information regarding patient's medical history, concomitant medications, past drugs, concurrent clinical presentation, and other risk factors precludes the complete medical case assessment.

Event Description

This case was cross referenced with cases: (b)(4) (cluster) this unsolicited case from united states was received on 16-nov-2017 from the non-health care professional.This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after unknown latency the patient experienced decrease mobility, inability to bear weight, pain and severe swelling; also, device malfunction was identified for the reported lot number.No relevant medical history, past medications and concomitant medications were reported.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 6 ml once (lot number: 7rls021 and expiration date: 31- may-2020) for osteoarthritis (oa) knee pain in the suprapatellar pouch of the left knee.On an unknown date in (b)(6) 2017, unknown latency of receiving the injection the patient experienced severe swelling, pain, decrease mobility, inability to bear weight.It was reported that the patient received bilateral injections on different days.Corrective treatment: unspecified for all the events.Outcome: recovering for all the events.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: (b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criterion: required intervention for all the events follow up information was received on 17-nov-2017.Related case id added.Text was mended accordingly.Additional information was received on 22-nov-2017.The event of device malfunction was added.The ptc results were added.Text amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 22-nov-2017: this case concerns a female patient who received treatment with synvisc one from recalled lot and later suffered from mobility decreased and weight bearing difficulty.Based on the available information, pharmacological plausibility can be established between the events and suspect product.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.

Event Description

This case was cross referenced with cases: (b)(4) (cluster).This unsolicited case from united states was received on 16-nov-2017 from the non-health care professional.This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after 7 days had decrease mobility/could barely scoot on floor to go to rest room/ could barely move at all due to pain and swelling, inability to bear weight/could not stand/unable to bear weight/ unable to apply any pressure on left leg, passed out, pain/weirdest pain i've ever had/ pain level increased quickly, severe swelling/ left knee swelling/ swelling continued to increase, felt ill, vomited, cold sweats and the injection even hurt different, it was debilitating; after unknown latency sounds like a flare of eczema and not a drug side effect or reaction.Also, device malfunction was identified for the reported lot number.No relevant concomitant medications were reported.Patient pain level was 0 before having injection.Patient was weight bearing before the injection.Patient denied having any prosthetic devices, denied treatment with immunosuppressants, denied allergies to avian protein, feathers, or eggs.Patient denied diabetes.Patient had penicillin allergy- hives and blisters on (b)(6) 2017, patient received first synvisc-one injection (different lot) in right knee and denied event.On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at the dose of 6 ml once (lot number: 7rsl021 and expiration date: 31-may-2020) for osteoarthritis (oa) knee pain in the suprapatellar pouch of the left knee and arthritis in knee with prp shots.On the same day, ( 7 days after receiving first synvisc one injection) patient had severs swelling 4 hours after the injection, felt ill, vomited, cold sweats, passed out.It was reported that tramadol pain medication was not working, "could barely scoot on floor to go to rest room, weirdest pain patient had ever had, the injection even hurt different, it was debilitating, patient could not stand.It was reported that the health care professional (hcp) prescribed tramadol only for pain, no ice, no elevation, no other treatment was recommended by hcp other than offering different narcotics for the pain.Patient was unable to bear weight after injection and used crutches after injection.Patient experienced severe swelling, pain, decrease mobility, inability to bear weight.It was reported that after an hour after the injection, swelling began in left knee.It was reported that swelling continued to increase and pain level increased quickly.Patient was unable to apply any pressure on left leg.Patient could barely move at all due to pain and swelling.It was reported that the patient received bilateral injections on different days.Patient pain level after injection was 9.Patient stated that "symptoms took 4-5 days to go away." patient was not sure if she had any fever, denies activities after recalled injection, no circumference measurements taken.Patient called her hcp the next day to report symptoms and received no treatment just was offered higher narcotics for the pain.The following week consumer received prp (platelet rich plasma) injection in right knee, 2 weeks after the recalled injection in the left knee she received prp (platelets) in her left knee.Patient denied labs, cultures or drainage performed by hcp after recalled injection, denied hospital stay.It was reported that the physician have not seen patient since (b)(6) 2017 and reported doing well.On an unknown date, latency unknown, patient had sounds like a flare of eczema and not a drug side effect or reaction.Corrective treatment: tramadol hydrochloride (tramadol) and hydrocodone bitartrate/paracetamol (vicodin) for pain/weirdest pain i've ever had/ pain level increased quickly; crutches, vicodin for decrease mobility/could barely scoot on floor to go to rest room/ could barely move at all due to pain and swelling; vicodin for inability to bear weight/could not stand/unable to bear weight/ unable to apply any pressure on left leg, severe swelling/ left knee swelling/ swelling continued to increase; not reported for rest events outcome: unknown for sounds like a flare of eczema and not a drug side effect or reaction; recovered for rest events reporter causality description: as per physician, a flare of her eczema and not a drug side effect or reaction.A pharmaceutical technical complaint (ptc) was initiated with global ptc number: 50511.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criterion: required intervention and disability for decrease mobility/could barely scoot on floor to go to rest room/ could barely move at all due to pain and swelling; required intervention inability to bear weight/could not stand/unable to bear weight/ unable to apply any pressure on left leg, device malfunction, pain/weirdest pain i've ever had/ pain level increased quickly, severe swelling/ left knee swelling/ swelling continued to increase; important medical event for passed out follow up information was received on 17-nov-2017.Related case id added.Text was mended accordingly.Additional information was received on 22-nov-2017.The event of device malfunction was added.The ptc results were added.Text amended accordingly.Upon internal review: lot number corrected in narrative additional information was received on 29-jan-2018.Verbatim was updated for the events of decrease mobility to decrease mobility/could barely scoot on floor to go to rest room; inability to bear weight to inability to bear weight/could not stand/unable to bear weight; pain to pain/weirdest pain i've ever had.Events of passed out, felt ill, vomited, cold sweats, the injection even hurt different, it was debilitating were added along with its details.Clinical course updated.Text was amended accordingly.Additional information was received on 13-feb-2018 from physician.Verbatim was updated for the event of decrease mobility/could barely scoot on floor to go to rest room to decrease mobility/could barely scoot on floor to go to rest room/ could barely move at all due to pain and swelling; inability to bear weight/could not stand/unable to bear weight to inability to bear weight/could not stand/unable to bear weight/ unable to apply any pressure on left leg; pain/weirdest pain i've ever had to pain/weirdest pain i've ever had/ pain level increased quickly; severe swelling to severe swelling/ left knee swelling/ swelling continued to increase.Event of sounds like a flare of eczema and not a drug side effect or reaction was added along with its details.Outcome was updated for the event of severe swelling/ left knee swelling/ swelling continued to increase from recovering to recovered.Patient allergy added.Clinical course updated.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 13-feb-2018: the follow up information received does not change the previous case assessment.This case concerns a female patient who received treatment with synvisc one from recalled lot and later suffered from mobility decreased, "pased" out and weight bearing difficulty.Based on the available information, pharmacological plausibility can be established between the events and suspect product.In addition, the concerned lot number has been identified to have malfunction by the company, hence, the causal relationship of the events to the product cannot be excluded.

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Brand Name

SYNVISC ONE

Type of Device

INTRA-ARTICULAR HYALURONIC ACID

Manufacturer (Section D)

GENZYME BIOSURGERY (RIDGEFIELD)

1125 pleadantview terrace

ridgefield NJ 07657

MDR Report Key

7071357

MDR Text Key

93359100

Report Number

2246315-2017-00218

Device Sequence Number

Product Code

MOZ

Combination Product (y/n)

PMA/PMN Number

P940015

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,health professional

Remedial Action

Recall

Type of Report

Initial,Followup,Followup,Followup

Report Date

11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

11/30/2017

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Other

Device Expiration Date

05/31/2020

Device Lot Number

7RLS021

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Date Manufacturer Received

02/13/2018

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention; Disability;

Patient Age

39 YR

Patient Weight

MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

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