MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER COCR HEAD FOR 12/14 TAPER (VERSYS); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

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

Patient Problems Failure of Implant (1924); Inflammation (1932); Rupture (2208); Test Result (2695)

Event Date 11/20/2015

Event Type  Injury  

Event Description

Pt id: (b)(6).On (b)(6) 2007, she received a left total hip arthroplasty of osteoarthritis of the left hip.Components included zimmer size 14 extended offset fiber metal taper stem, 32mm +0 cocr head, a 54 od trilogy socket and a 32mm polyethylene liner.Metal suppression mri of the left hip made on (b)(6) 2015 showed a large cystic pseudotumor of the left hip with denuded greater trochanter.On (b)(6) 2016, plasma cobalt level was 11.4 mcg/l, and on (b)(6) 2016, urine cobalt level was 7.2 mcg/l.On (b)(6) 2016, the left tha was revised due to an adverse reaction to metallic debris and elevated blood cobalt levels.The prior 32 mm chrome-cobalt head and liner were exchanged for 28 mm +3.5 biolox delta option ceramic head and a constrained liner.The fiber metal taper stem was retained.She had a significant adverse reaction to metallic debris which involved the hip abductor tendons, which were partially ruptured by about 50%.The head bore and trunnion showed marked corrosion.Frozen section of soft tissue from the left hip joint was given the diagnosis of aseptic lymphocytic vasculitis associated lesion by pathology.On (b)(6) 2016, about 6 weeks after revision, her urine cobalt level was 2.9 mcg/l and her whole blood cobalt level was 6.2 mcg/l, and blood chromium was 3.1 mcg/l.Fda safety report id# (b)(4).

• Brand Name: ZIMMER COCR HEAD FOR 12/14 TAPER (VERSYS)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V. ; warsaw IN
• MDR Report Key: 9695286
• MDR Text Key: 179279367
• Report Number: MW5092930
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/07/2020

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: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• 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: 80 YR
• Patient Weight: 59