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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Arthritis (1723); Fever (1858); Rash (2033); Chills (2191); Therapeutic Response, Decreased (2271); Joint Disorder (2373); No Code Available (3191)
Event Date 11/01/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction]. Symptoms had worsened since last visit [condition aggravated]. Rash on the right knee intermittently [localised rash]. Contact dermatitis unspecified on the trunk [contact dermatitis]. ([red rash], [itchy rash]) fever [fever]. Chills [chills]. Acute inflammatory reaction to the injection [joint inflammation]. ([effusion (r) knee], [aching (r) knee], [swelling of r knee], [condition worsened]) felt hot [joint warmth]. Patient was 0% better since last visit [therapeutic response decreased]. Case narrative: initial information received on 11-oct-2019 from united states regarding an unsolicited valid legal serious malfunction case from a lawyer. This case involves a (b)(6) years old male patient (170. 1 cm and 103 kg) who experienced device malfunction (latency: unknown), contact dermatitis unspecified on the trunk (latency: 1 year 1 month 22 days), fever, chills, rash on the right knee intermittently (latency: unknown), symptoms had worsened since last visit (latency: 5 days), acute inflammatory reaction to the injection (latency: unknown), felt hot (latency: unknown) and patient was 0% better since last visit (latency: 5 days), while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc one). Additionally, the event of device malfunction was added for the identified recall lot. The patient's past medical history included left total knee arthroplasty on (b)(6) 2017, abdominal hernia repair, total knee replacement right knee on (b)(6) 2017, lasix eye surgery, vasectomy, polypectomy and colonoscopy. At the time of the event, the patient had ongoing pain right shoulder and left shoulder since 2014, mild arteriosclerosis since (b)(6) 2017, left knee pain, muscle weakness (generalized), difficulty in walking, stiffness of left knee, left artificial knee joint and osteoarthritis. Family history included hypothyroidism, hypertension, heart disease and lung cancer. The patient's past medical treatment(s) and vaccination(s) were not provided. Patient did not consume alcohol, was a non-smoker. No family history of melanoma. Patient had allergies to antibiotics for long period of time. Patient had anemia, infectious disease, sleeping problems/difficulties, severe or frequent headaches, vision or hearing difficulties, numbness or tingling, dizziness or fainting, weight loss/energy loss concomitant medications included tramadol. On (b)(6) 2017, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate in his right knee at dosage 1 df, frequency once (lot: 7rsl021, exp 31-may-2020) for osteoarthritis local primary lower leg right. Under aseptic technique and with patients consent, right knee was injected with hylan g-f 20, sodium hyaluronate. The patient tolerated the procedure well and was instructed to use ice to control any post injection discomfort. The patient was given post injection instructions. On an unknown date in (b)(6) 2017, since the injection, patient had significant pain, swelling in the knee and an acute inflammatory reaction to the injection (latency: unknown). On (b)(6) 2017, patient reported for follow up of his right knee and his symptoms had worsened since last visit (latency: 5 days). Patient was oriented to time, place and person. The patent's mood and affect were appropriate. Patient's pain was severe with a rating of 8/10, patient was 0% better since last visit (latency: 5 days). There was no change in character or location of the problem, no new symptoms or accompaniments. The patient also had moderate to large effusion (latency: 5 days), no erythema and no signs of infection. As a corrective, patient was given nsaids and told to continue ice and elevation. On (b)(6) 2017, patient resumed work, as he was on leave due to the discomfort caused by the injection. On (b)(6) 2017, patient reported for follow up and mentioned there had been improvement in the symptoms since last visit. Pain was mild and rated it 2 on a scale of 10. Patient was 80% better since last visit. He had no signs of infection and had full range of motion and was feeling much better in the right knee following a significant reaction following the injection. Reportedly, there was a potential contamination with bacteria of the lot that the patient received intra-articular into the right knee. There was no change in character or location of the problem, no new symptoms or accompaniments. On (b)(6) 2018, patient reported to the clinic with concerns related to the left knee arthroplasty he had in the past and reported he was much better. Impression of x-ray done on (b)(6) 2018: for left knee had excellent outcome thus far after left knee total arthroplasty; end stage degenerative joint disease (djd) of the right knee had excellent response to synvisc injection. Patient had to return in 6 months for follow up. Upon visit, 2 x-rays were done to review the arthroplasty components. On (b)(6) 2018, patient visited for follow up of his left knee arthroplasty and rated his pain moderate and stated left knee had been swollen since monday. Patient had some mild redness at 2 pinpoint spots on the medial aspect of left knee. On (b)(6) 2018, patient reported that left knee arthroplasty pain had become worse and patient underwent lab tests, synovial fluid samples were taken from the left knee to check for infection and were sent for synovasure. On (b)(6) 2018, patient visited again for follow up of left knee arthroplasty and mentioned that he was better since last visit and had improved. On (b)(6) 2018, his left knee was much better. His left knee was aspirated to check for any infections, post the arthroplasty. On (b)(6) 2018, patient reported with the complaint of swelling on the right knee, pain which was intermittent and worsened since the past 3 weeks. Patient also reported he got a rash on the right knee intermittently (latency: unknown) and reported it felt hot (latency: unknown), had fever (latency: unknown) and chills (latency: unknown). Hyperpigmentation was also noted on the left knee. On (b)(6) 2018, patient was diagnosed with contact dermatitis unspecified on the trunk (latency: 1 year 1 month 22 days) and had a patch test done. His rash was itchy, asymptomatic, red and moderate in severity. On (b)(6) 2019, patient reported to the clinic for follow up of his dermatitis. The rash had been present for months. The patches were well demarcated, geometric eczematous and located on the trunk. On (b)(6) 2019, patient underwent surgery again to correct his arthroplasty due to chronic concerns of pain underwent insertion of an antibiotic spacer. On (b)(6) 2019, patient received 30 mg of orthovisc injection in his right knee for second time, under aseptic conditions. The patient tolerated the procedure well and was instructed to use ice to control any post injection discomfort. On (b)(6) 2019, patient received 30 mg of orthovisc for the third time. On (b)(6) 2019, patient underwent surgery for exchange of left knee antibiotic spacer. On (b)(6) 2019, patient was diagnosed with septic arthritis of his left knee. On (b)(6) 2019, patient reported for follow up after his left knee surgery and reported his pain had decreased. On (b)(6) 2019, patient visited for his chronic complaint of pain right shoulder and left shoulder which he had since 5 years. Pain was severe with rating of 9/10. The pain was defined as sharp, stabbing and aching and was worse upon lifting and reaching over head. The patient received an injection of depomedrol for his chronic shoulder pain. On (b)(6) 2019, patient underwent revision total left knee arthroplasty as his left knee was infected. The patients antibiotic spacer was removed, left revision total knee arthroplasty and let knee patellar tendon repair was done. After the surgery, no infection was noted. On (b)(6) 2019, patient reported for follow up visit and still had complaints of left knee pain, difficulty in walking and muscle weakness (generalized). Patient reported difficulty in going up and down the stairs and ambulated with an antalgic gait pattern. He was currently ambulating with sp cane and struggled to ambulate prolonged periods of time secondary to lack of endurance. Functionally patient was having difficulty with prolonged standing, weight bearing tolerance, negotiating stairs, engaging in regular exercise routine, and household / work related activities mainly due to pain, weakness, and limited mobility. On (b)(6) 2019, patient complained of giving away of left knee when walking without brace. On (b)(6) 2019, at his follow up visit patient stated that he was able to ambulate safely in community setting. As of (b)(6) 2019, patient had continued difficulty with activities of daily living and household activities. On (b)(6) 2019, at his follow up visit patient rated his left knee pain at 4 on a scale of 10 and showed steady improvement with strength and ability to walk. On (b)(6) 2019, patient had x-rays done of her left knee to assess the arthroplasty components. Action taken: not applicable for all events. Corrective treatment: nsaids, ice and elevation for acute inflammatory reaction to the injection; not reported for rest of the events. Outcome: recovering/resolving for symptoms had worsened since last visit; not recovered/not resolved for device malfunction, acute inflammatory reaction to the injection; not applicable for patient was 0% better since last visit; unknown for rash on the right knee intermittently, felt hot, fever, chills, contact dermatitis unspecified on the trunk. An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from 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.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key9225860
MDR Text Key176599693
Report Number2246315-2019-00266
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 10/23/2019 Patient Sequence Number: 1
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