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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 Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)
Patient Problems Fever (1858); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 11/07/2017
Event Type  Injury  
Event Description
Device malfunction [device malfunction]. Not been able to walk/unable to walk [walking difficulty]. Pain in both knees [knee pain] ([pain aggravated]). Swelling in both knees [knee swelling]. Fever [fever]. Limited range of motion [joint range of motion decreased]. Bilateral hip osteoarthritis [osteoarthritis]. Wbc slightly elevated [white blood cell increased]. Sedimentation rate slightly increased [sedimentation rate increased]. Crp are slightly elevated [c-reactive protein increased]. Bilateral knee severe osteoarthritis/osteoarthritis of the left knee [osteoarthritis knee] ([knee swelling], [redness], [joint warmth], [pain upon movement], [joint effusion]) atherosclerosis of extremities [atherosclerosis]. Lumbar degenerative disease at l4-l5 and l5-s1 [lumbar disc degeneration]. Frustrated [frustration]. Platelet count increased [platelet count increased]. Case narrative: this unsolicited case from united states was received on 26-fevb-2018 from a healthcare professional (doctor). This case involves a (b)(6) years old female patient who received treatment with synvisc one and after unknown latency experienced pain in both knees, swelling in both knees, not been able to walk/unable to walk, fever, limited range of motion, bilateral hip osteoarthritis, bilateral knee severe osteoarthritis/osteoarthritis of the left knee, platelet count increased and frustrated, after 1 month and 20 days had lumbar degenerative disease at l4-l5 and l5-s1, after 3 months and 09 days had wbc slightly elevated, after 2 months and 26 days sedimentation rate slightly increased, crp are slightly elevated and atherosclerosis of extremities. Also, device malfunction was identified for the reported lot number. Medical history included bilateral knee pain since she was in military in 1970 to 1991. Bilateral knee pain started to get worse around 2013. Patient had received hyaluronic acid injections in the past and it helped and patient did well for about three years. Patient was diagnosed with colon polyp and iron deficiency anemia (on (b)(6) 2017), nonischemic cardiomyopathy (on (b)(6) 2016) and cardiomyopathy, chf (congestive heart failure), hypertension, hyperlipidemia, diabetes mellitus and right bundle branch block (rbbb) (all diagnosed on (b)(6) 2014). Patient also had gerd (gastroesophageal reflux disease), gout, left leg pain, osteoarthritis, vitamin d deficiency and wrist fracture, left. Surgical history included appendectomy, cesarean section, classic x2, colon surgery, wrist surgery (x3; done for left wrist fracture repair). Patient was allergic to carvedilol (vaginal and rectal itching) and shellfish containing products. Patient was never a smoker. Family history included heart failure, coronary artery disease and diabetes in mother, coronary artery disease, heart failure and diabetes in father and coronary artery disease, diabetes in brother. Concomitant medications included salbutamol sulfate (albuterol) for wheezing/shortness of breath, acetylsalicylic acid (aspirin (e. C. ), ferrous sulfate anhydrous, fosinopril sodium (monopril), furosemide (lasix), hydrocodone bitartrate, paracetamol (lortab/vicodine), ibuprofen sodium (ibuprofen), ivabradine hydrochloride (corlanor), metformin hydrochloride (glucophage), metoprolol succinate (toprol xl), omeprazole magnesium (prilosec), pravastatin sodium (pravachol), spironolactone (aldactone), vitamin d2. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection, at a dose of 6 ml, once (batch/lot number: 7rsl021; expiration date: 31-may-2020) in both knees for worsening bilateral knee osteoarthritis. It was reported that the lot was recalled due to bacteria (methylobacterium thiocyanatum) in the injections and the patient was suspected to have synvisc infection. On the same day, about 2 hours after the injection, patient had left knee swelling, redness, warmth, and pain. These symptoms continued for 3-4 weeks. On (b)(6) 2017, patient noted improvement in right knee pain, but worsening pain in left knee. On (b)(6) 2017, patient's lumbar plain radiograph showed that there was minimal grade 1 anterolisthesis of l4 on l5. Lumbar spine alignment was otherwise normal. Phleboliths were noted in the pelvis. There was bilateral hip osteoarthritis, mild in severity. Final diagnosis was moderate lumbar degenerative disease at l4-l5 and l5-s1. No compression fractures. On the same day, patient's left knee plain radiograph showed that there was severe tricompartmental osteoarthritis of the left knee with medial and lateral compartment predominance. There was a small left knee effusion which appears decreased in volume compared to the prior radiograph. No focal soft tissue swelling near the left knee. No acute fracture. There was atherosclerosis of the left distal femoral artery and popliteal artery. Patient was unable to walk at that time (onset date: unknown). The left knee swelling, redness, and warmth had resolved. Patient walks with a walker and used a wheelchair when ambulating for long periods. Patient still had pain (b)(6) in the left knee which occurred when she was walking or standing or moving her left knee. Patient had little to no pain in the left knee when she was still and not moving the left knee. On (b)(6) 2018, patient had left knee pain. Patient had a reaction to the synvisc and had fever and swelling of both knees. Patient was not able to walk since having the synvisc injections. On (b)(6) 2018, patient was also followed by vascular surgery for atherosclerosis of extremities and she was seen physician on the same day and noted to have "abis nl" and also "feet well perfused" and no indication for vascular intervention. On the same day, patient's sedimentation rate (sed) rate was 36 mm/hr; high (reference range: 0-20), c-reactive protein (crp) was 2. 6 mg/dl; high (reference range: 0-1. 0) and procalcitonin level was normal i. E 0. 05 ng/ml (reference range: <0. 10). As of (b)(6) 2018, patient had physical therapy which had not helped. There had been no change in her symptoms. On an unknown date, after unknown latency, physician noted that the patient had limited range of motion and pain with movement of the left knee. On the same day, physician attempted a left knee aspiration, but there was no fluid to be aspirated. On the same day, 3 months and 09 days after the injection, patient was diagnosed with knee severe osteoarthritis and left greater than right with left one terribly symptomatic for the last 8 weeks. On the same day, 3 months and 09 days after the injection, patient's white blood cell (wbc) was slightly elevated. As of (b)(6) 2018, it was reported that now patient continued left knee pain with movement. On the same day, patient's wbc was 11. 6 x 10e3/mcl (reference range: 3. 8-10. 8) (h), platelet: 560 x 10e3/mcl (reference range: 140-400) (h), absolute neutrophil: 8097 cells/mcl (h) (reference range: 1500-7500), eosinophil absolute: 719 cells/mcl (reference range: 15-500) (h), sedimentation rate: 38 mm/h, crp: 42. 5 mg/l (reference range: <8. 0 mg/l) and blood glucose: 117 mg/dl (h) (reference range: 65-99). As of (b)(6) 2018, patient still had pain in both knees which was worse in the left knee (rated 7/10) than right knee and her pain occurred with movement of the knees (onset date: unknown). Patient was frustrated with the continued knee pain (onset date: unknown). Patient denied pain in knees when her knees were not moved. This seemed to be more likely osteoarthritis of the left knee rather than a septic left knee. Physician did not think that the patient had left knee septic arthritis as her clinical exam had no evidence of infection as left knee was without redness or warmth and there was only minor swelling in the left knee which appeared the same as the right knee. It was reported that the patient had some mild swelling of both knees which was not worsening. Patient denied redness or warmth of the knees. Patient had not been on any antibiotics for this potential infection exposure. On the same day, patient's crp: 11. 6 (h), wbc: 12 (h), platelets: 506 thousand/mcl, eosinophil absolute: 984 cells/mcl (h)(reference range: 15-500), on (b)(6) 2018, patient's wbc: 11. 1 (h), rdw: 15. 5% (h) (normal: 11-15), eosinophil absolute: 833 cells/mcl (h), crp: 38. 8 mg/l, sedimentation rate: 43 mm/h (h) and platelet: 507 (h). Corrective treatment: physical therapy for pain in both knees, swelling in both knees, limited range of motion, bilateral knee severe osteoarthritis/osteoarthritis of the left knee; not reported for rest all the events. Outcome: recovered/resolved for swelling in both knees; not recovered/not resolved for bilateral knee severe osteoarthritis/osteoarthritis of the left knee and unknown for rest of the events. A product technical complaint 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 is completed, corrective and preventive actions would be implemented. Seriousness criteria: disability for device malfunction and not been able to walk/unable to walk. Follow-up information was received on 02-mar-2018. Global ptc number was added. Additional information was received on 03-jul-2018 from a physician. Patient's demographics were added. Medical history and concomitant medications were added. Additional events of not been able to walk/unable to walk, fever, limited range of motion, bilateral hip osteoarthritis, bilateral knee severe osteoarthritis/osteoarthritis of the left knee, platelet count increased and frustrated, lumbar degenerative disease at l4-l5 and l5-s1, wbc slightly elevated, sedimentation rate slightly increased, crp are slightly elevated and atherosclerosis of extremities were added along with details. Corrective treatment for pain in both knees, swelling in both knees was added. Clinical course was updated and text was amended accordingly.
 
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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 Key9990047
MDR Text Key196846565
Report Number2246315-2018-00877
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
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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
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: 04/23/2020 Patient Sequence Number: 1
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