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

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

Patient Problems Inflammation (1932); Pain (1994); Local Reaction (2035); Arthralgia (2355); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Decreased ability to bear weight [weight bearing difficulty].Acute onset of unilateral severe knee pain [knee pain].Acute onset of unilateral severe knee swelling [knee swelling].Acute onset of severe tense knee effusion (unilateral) [knee effusion].Case narrative: initial information received on 08-jan-2007 regarding a solicited valid serious case issued from a literature article: leopold ss, warme wj, pettis pd, shott s.Increased frequency of acute local reaction to intra-articular hylan gf-20 (synvisc) in patients receiving more than one course of treatment.The journal of bone and joint surgery 2002 ;84-a(9) :1619-23.Digital object identifier: 10.2106/06304623-200209000-0001s, in the scope of post-marketing sponsored study.The case is linked to case ids (b)(6) (clusters).Patient id: unknown; country: united states.Study title: unsponsored study involving synvisc.The study was performed to test the hypothesis that the likelihood of a painful reaction to hylan gf-20 does not increase in patients who receive more than one course of treatment.The article described results from a study conducted between (b)(6) 2000 and (b)(6) 2001, wherein the records of all patients who had received more than one series of synvisc were compared with a group of 100 patients who had received only one series and who were subsequently enrolled in a prospective, randomized trial comparing intra-articular corticosteroid injections with synvisc for the treatment of noninflammatory arthritis of the knee.All patients completed a course of three weekly injections of synvisc according to manufacturers' instructions, unless they exhibited an acute local reaction to synvisc, which was defined as acute onset of pain and swelling in the knee occurring within 72 hours after injection.This case involves a 49-year-old male patient who experienced acute onset of unilateral severe knee swelling, acute onset of severe knee swelling, decreased ability to bear weight and tense knee effusion while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.Patient had ongoing history of bilateral non-inflammatory knee arthritis and degenerative joint disease (djd).The patient had been one of 42 patients (57 knees) who had received a single course of hylan g-f 20, sodium hyaluronate course (three weekly injections; 3x) (dose, route, form, batch/lot details: unknown) injections between (b)(6) 2000 and (b)(6) 2001 for bilateral noninflammatory arthritis, as part of a prospective, randomized clinical trial which had compared intra-articular corticosteroid injections with hylan gf-20 injections.On an unknown date, patient experienced "an acute local reaction," which manifested itself as severe knee pain (arthralgia), knee swelling (joint swelling), a decreased ability to bear weight (weight bearing difficulty) and tense knee effusion (joint effusion) within less than 6 hours after a first injection of synvisc in a first series.All the acute local reactions were described as severe.The knee symptoms had been treated with an intra-articular corticosteroid injection and aspiration; and the patient had recovered from the events without sequelae.At the time frame between 3 months to less than one year after having received the course of synvisc injections, the patient also experienced a degenerative meniscal tear.The tear had been treated with arthroscopic lavage and debridement.The lead author reported "there is no way to know for sure when the meniscal tear occurred.It was a typical degenerative tear and existed alongside the patient's djd of the knee.There is no reason at all to believe synvisc caused the tear." the patient's clinical outcome regarding the meniscal tear had not been reported.The authors concluded that there was a highly significant increase in the frequency of acute local reactions in patients who were treated with multiple series of synvisc compared with the patients who were in the prospectively followed group and who had only received one series of synvisc.Seriousness: intervention required for all events.Action taken: unknown for all events.Corrective treatment: intra-articular corticosteroid injections and aspiration for all events.Outcome: recovered for all events.Reporter causality: related for all events.Additional information was received from article on 30-may-2022: literature reference updated.Concurrent condition updated.Study type updated.Corrective treatment added.Seriousness criteria was updated to intervention required.Event linking was updated for weight bearing difficultly.Intensity of events added.Dosing details and action taken updated for synvisc.Lab test added.Event deleted- degenerative meniscal tear.Event added weight bearing difficulty.Narrative was updated accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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: 14785736
• MDR Text Key: 295059707
• Report Number: 2246315-2022-00067
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male