MAUDE Adverse Event Report: STRYKER / HOWMEDICA OSTEONICS CORP. STRYKER ACCOLADE 36MM+5 COCR HEAD; PROSTHESIS,HIP,SEMI-CONSTRAINED METAL/CERAMIC/POLYMER,CEMENTED NON-POROUS,UNCEME

Catalog Number 6077-0335

Device Problems Corroded (1131); Material Fragmentation (1261)

Patient Problems Edema (1820); Emotional Changes (1831); Failure of Implant (1924); Inflammation (1932); Left Ventricular Dysfunction (1947); Memory Loss/Impairment (1958); Necrosis (1971); Neurological Deficit/Dysfunction (1982); Numbness (2415); Sleep Dysfunction (2517); Test Result (2695)

Event Date 03/26/2015

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2010, the pt received a left total hip arthroplasty.The left hip implant consists of a stryker accolade cobalt-chrome hfx stem with a 36mm+5 cocr head, a 50 psl, socket and 36 internal diameter x3 polyethylene liner and a single acetabular screw.Details from the implant stickers include the following: lfit v40 head size 36mm, +5mm offset, v40 taper, ref #(b)(4), lot # mjel2v; accolade hfx 127 degree neck angle hip ste size 3, 35mm neck length, 120mm stem length, v40 taper, ref #(b)(4), lot # mjkl3m.On (b)(6) 2014, cobalt urine level was 19 mcg/l and serum cobalt level was 4.0 mcg/l.Around the same time, the pt also developed uncharacteristic crankiness, memory problems, vision problems, word finding issues.Her neurological problems were so concerning that she sought neuropsychological evaluation.The pt also noted having increased latency to sleep, and during this same time the pt also experienced increasing numbness of both hands more so the right than the left hand.On (b)(6) 2015, pt underwent an echocardiogram which showed grade 1 diastolic dysfunction, mild left ventricular hypertrophy, and a slightly increased right ventricle pressure.On (b)(6) 2015, the left hip was revised due to elevated cobalt levels in blood and urine and new neurological problems suggesting possible arthroplasty cobalt toxicity.The superficial periprosthetic tissue appeared inflamed and edematous.Frozen section of left hip tissue did not meet criteria for acute inflammation.Pathologist noted perivascular lymphocytic cutting which is a feature of aseptic lymphocytic vasculitis associated lesions.The trochanteric bursa was effused, the inferior posterior capsule was deferent and the joint communicated with the trochanteric bursa, the anterior capsule was thickened and the serosal side appeared necrotic.The socket was well positioned and ingrown so it was not revised.The hip abductor tendons were not compromised.There are about 200 cc of turbid fluid about the hip.Corrosion was noted at the neck stem taper junction internally and was noted externally before separating the taper.After reconstruction there was a sound repair of the trochanteric fracture.Length was not changed as planned.Anterior capsule was intact and posterior capsule was repairable.Fluid was collected from the left hip joint and the cobalt level was 140 mcg/dl and the chromium level was 130 mcg/l.The revision implant was a zimmer wagner 16mm, 190mm stem delta ceramic 36mm +7 head 4 luque wires, 90cc mtf allopack graft with 1 gram vancomycin.The acetabular component was retained.Formal explant analysis indicated that the bore of the cobalt chrome head had corrosion involving 10%-50% of the surface.The pt's post-revision urine cobalt level was checked on (b)(6) 2019, and it was lowered to 1.3 mcg/l.Fda safety report id# (b)(4).

• Brand Name: STRYKER ACCOLADE 36MM+5 COCR HEAD
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED METAL/CERAMIC/POLYMER,CEMENTED NON-POROUS,UNCEME
• Manufacturer (Section D): STRYKER / HOWMEDICA OSTEONICS CORP.
• MDR Report Key: 9586044
• MDR Text Key: 175199695
• Report Number: MW5092198
• Device Sequence Number: 2
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6077-0335
• Device Lot Number: MJKL3M
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 96