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

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

Patient Problems Arthritis (1723); Fall (1848); Muscle Spasm(s) (1966); Arthralgia (2355); Neck Pain (2433); No Code Available (3191)

Event Date 06/08/2015

Event Type  Injury  

Event Description

Somnolent/hard time staying awake [sleepy], excruciating pain in my legs [pain legs], excruciating pain in my shoulders [shoulder pain], severe leg spasms [spasms], left knee began giving out [unspecified disorder of knee joint], torn meniscus/a torn meniscus in the left knee/a complex tear of the meniscus in the right knee [meniscus tear], hip bursitis [hip bursitis], pseudogout [pseudogout], broken neck [neck injury], fell/had more falls [fall], neck pain [neck pain], pseudoseptic acute arthritis/systemic pseudoseptic acute arthritis/inflammation [pseudoseptic arthritis], ([device use issue], ) excruciating pain in my ankles, knees, hips [joint pain].Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request.This unsolicited case from united states was received on 06-apr-2018 via health authority usa-fda (reference number: mw5075286) from the health care professional.This case concerns a patient (age, gender unspecified) who received treatment with synvisc one injection and same day developed somnolent/hard time staying awake, excruciating pain in my legs, excruciating pain in my shoulders, severe leg spasms, left knee began giving out(latency: few days), torn meniscus/a torn meniscus in the left knee/a complex tear of the meniscus in the right knee, pseudoseptic acute arthritis/systemic pseudoseptic acute arthritis/inflammation, hip bursitis, pseudogout, torn tendons(latency: unk), broken neck(latency: unk), excruciating pain in my ankles, knees, hips and fell/had more falls (latency: few days).No relevant medical history, concomitant medications and concurrent condition were reported.Patient had 4-5 synvisc injections privately over 3-4 years with excellent results.On (b)(6) 2015, the patient received treatment with intra-articular synvisc one injection, once for unknown indication (dose: unknown).The same day patient developed somnolent/hard time staying awake, excruciating pain in my legs, excruciating pain in my shoulders, severe leg spasms and excruciating pain in my ankles, knees, hips.On an unknown date in (b)(6) 2015, few days after initiating treatment, patient's left knee began giving out.On an unknown date in 2015, after unknown latency, patient had fell/had more falls , torn meniscus/a torn meniscus in the left knee/a complex tear of the meniscus in the right knee and the injection went into the tissue and caused inflammation.On an unknown date, after unknown latency, patient developed pseudoseptic acute arthritis/systemic pseudoseptic acute arthritis, hip bursitis, pseudogout, torn tendons and broken neck.Corrective treatment: not reported for all the events.Outcome: unknown for all the events.Seriousness criteria: medically significant for all the events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Pharmacovigilance comment: sanofi company comment dated 16-apr-2018: based on the information received, the causal relationship between the suspect product and event could not be denied.Also, lack of information regarding patient's medical history, concurrent illness, concomitant medication and lab tests leads to incomplete assessment of the case.

Event Description

This unsolicited case from united states was received on 06-apr-2018 via health authority usa-fda (reference number: mw5075286) from the health care professional.This case concerns a patient (age, gender unspecified) who received treatment with synvisc one injection and same day developed somnolent/hard time staying awake, "excruciating" pain in my legs, "excruciating" pain in my shoulders, severe leg spasms, left knee began giving out(latency: few days), torn meniscus/a torn meniscus in the left knee/a complex tear of the meniscus in the right knee, pseudoseptic acute arthritis/systemic pseudoseptic acute arthritis/inflammation, hip bursitis, pseudogout, torn tendons(latency: unk), broken neck(latency: unk), "excruciating" pain in my ankles, knees, hips and fell/had more falls (latency: few days).No relevant medical history, concomitant medications and concurrent condition were reported.Patient had 4-5 synvisc injections privately over 3-4 years with excellent results.On (b)(6) 2015, the patient received treatment with intra-articular synvisc one injection, once for unknown indication (dose: unknown).The same day patient developed somnolent/hard time staying awake, "excruciating" pain in my legs, "excruciating" pain in my shoulders, severe leg spasms and "excruciating" pain in my ankles, knees, hips.On an unknown date in (b)(6) 2015, few days after initiating treatment, patient's left knee began giving out.On an unknown date in 2015, after unknown latency, patient had fell/had more falls, torn meniscus/a torn meniscus in the left knee/a complex tear of the meniscus in the right knee and the injection went into the tissue and caused inflammation.On an unknown date, after unknown latency, patient developed pseudoseptic acute arthritis/systemic pseudoseptic acute arthritis, hip bursitis, pseudogout, torn tendons and broken neck.Corrective treatment: not reported for all the events outcome: unknown for all the events seriousness criteria: medically significant for all the events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Pharmacovigilance comment: sanofi company comment dated 16-apr-2018: based on the information received, the causal relationship between the suspect product and event could not be denied.Also, lack of information regarding patient's medical history, concurrent illness, concomitant medication and lab tests leads to incomplete assessment of the case.

• 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: 7478876
• MDR Text Key: 213409555
• Report Number: 2246315-2018-00458
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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; Other