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U.S. Department of Health and Human Services

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

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GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Paralysis (1997); Sepsis (2067); Weakness (2145); Chills (2191); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Disability (2371); Joint Disorder (2373); Joint Dislocation (2374); Weight Changes (2607); Alteration In Body Temperature (2682); No Code Available (3191)
Event Date 12/07/2017
Event Type  Injury  
Event Description
Pseudosepsis reaction following synvisc one injection [pseudosepsis] ([residual pain], [inflammatory reaction]), uses a walker for ambulation [walker user] , wheelchair for transportation [wheelchair user], prosthetic joint infection [joint infection], device malfunction [device malfunction], left knee discomfort [discomfort in joints], left knee discomfort with weight bearing activities and stair climbing [weight bearing difficulty], burning in the lower left extremity/ burning in the bilateral feet [burning sensation], swelling in the leg has improved/ heavy swelling to her foot and ankles [swelling of legs], c reactive protein high [c-reactive protein result high], erythrocyte sedimentation rate high [erythrocyte sedimentation rate high], aspiration of knee [effusion (l) knee], gained weight [weight gain], no longer able to use elliptical machine [inadequate exercise]. Case narrative: this unsolicited case from united states was received on 10-may-2018 from physician. This case concerns a (b)(6) female patient who received treatment with synvisc one injection and after 3 days, developed c reactive protein high, erythrocyte sedimentation rate high; after 27 days patient experienced pseudosepsis reaction and after unknown latency, developed prosthetic joint infection, uses a walker for ambulation, wheelchair for transportation, left knee discomfort, left knee discomfort with weight bearing activities and stair climbing, burning in the lower left extremity/ burning in the bilateral feet, swelling in the leg has improved/ heavy swelling to her foot and ankles, aspiration of knee, gained weight and no longer able to use elliptical machine. A device malfunction was identified in the reported lot number. No relevant past drugs were reported. Patient had undergone left valve surgery on groin, c4 corpectomy, ankle/foot surgery (2002) neuromas removed in left foot, back/spine surgery - cervical laminectomy, back/spine surgery - spinal fusion, ovary removal both, head or neck surgery - brain surgery--aneurism repair complicated by cva, hysterectomy. Patient had stroke, thyroid problems, left hemiparesis, left knee pain, eye irritation, sinus problems, snoring, known heart murmur, sleep apnea, gerd, urinary loss of control, muscle aches, aches, weakness, arthralgia, back pain, rash, abdominal mole, cold intolerance, itching, runny nose and osteoarthritis of knee. Concomitant medications included diazepam, econazole, ergocalciferol, estradiol (estrace), folic acid, gabapentin, hydrocodone/paracetamol (acetaminophen w/hydrocodone), levothyroxine sodium (levothyroxine), tramadol hydrochloride (tramadol) and trospium. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, at a dose of 6 ml once for osteoarthritis of knee and bilateral knee pain (lot no. 7rsl021 and expiration number 31-may-2020). On an unknown date, after an unknown latency, patient experienced prosthetic joint infection, uses a walker for ambulation, wheelchair for transportation, left knee discomfort, left knee discomfort with weight bearing activities and stair climbing, burning in the lower left extremity/ burning in the bilateral feet, swelling in the leg has improved/ heavy swelling to her foot and ankles, aspiration of knee, gained weight and no longer able to use elliptical machine. On (b)(6) 2017, 3 days after initiating treatment, patient had c reactive protein high and erythrocyte sedimentation rate high. On (b)(6) 2017, 27 days after initiating treatment, patient developed pseudosepsis reaction was hospitalized for a few days in new mexico after receiving an injection. On (b)(6) 2018, patient was still having a lot of pain and it was hard to bear weight or climb stairs and says her condition was worse because of the injection. Patient was already requesting records and was looking for documentation to show that this all happened due to injection. Patient experienced pseudosepsis rxn requiring hospitalization. Continues to experience a great deal of discomfort and significant pain as of (b)(6) 2018. Patient continues to have left knee discomfort after receiving a synvisc injection to the knee on (b)(6) 2017. Patient was no longer able to use her elliptical machine. Patient also gained weight and had burning in the lower left extremity. The swelling in the leg improved. Patient was currently taking nothing for analgesia. Patient continues to use a walker and a wheelchair. After discussion of the risks and benefits, the patient elected to proceed with an aspiration of the left knee(s). Informed consent was obtained. There was no erythema, or warmth, and the skin was clear. The skin was prepped in the usual sterile fashion with betadine. A 18 gauge needle was inserted into the joint via a superolateral approach. The joint was then aspirated and 20 cc of normal appearing fluid was obtained. The fluid was carefully placed into the appropriate vials, labelled and sent to the lab for analysis. The injection was completed without complication, and a bandage was applied. The patient tolerated the procedure well and was instructed to avoid strenuous activity for the next 24-48 hours and to use ice, nsaids, or tylenol for pain as needed. Patient was given a prescription for norco to help with her pain control. She was given prescription for lab work. Patient was discharged with sulfarnethocazole, trimethoprim, hydrocodone, acetarninophen medications. Corrective treatment: not reported for all the events. Outcome: unknown for all the events. 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: hospitalization or prolongation for pseudosepsis reaction following synvisc one injection; important medical event for prosthetic joint infection and device malfunction; disability for uses a walker for ambulation and wheelchair for transportation. Additional information received on 29-may-2018. No new information received.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME BIOSURGERY (RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
MDR Report Key7582953
MDR Text Key110536254
Report Number2246315-2018-00485
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/08/2018 Patient Sequence Number: 1
Treatment
DIAZEPAM (DIAZEPAM),TABLET; ECONAZOLE (ECONAZOLE),UNKNOWN; ERGOCALCIFEROL (ERGOCALCIFEROL),CAPSULE; ESTRACE (ESTRADIOL),CREAM; FOLIC ACID (FOLIC ACID),TABLET; GABAPENTIN (GABAPENTIN),CAPSULE; HYDROCODONE/PARACETAMOL,TABLET; LEVOTHYROXINE (LEVOTHYROXINE),TABLET; TRAMADOL (TRAMADOL),TABLET; TROSPIUM (TROSPIUM),TABLET
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