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

Device Problem Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 03/15/2016

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2005, she received a left tha involving a zimmer fiber metal taper with 32 mm metal-on-plastic articulation.On the right side, she has an osteonics omni flex stem with a 22 mm chrome-cobalt on plastic articulation, which was implanted on (b)(6)1992.Both hips consist of cocr components, but historically, the zimmer 12/14 taper and zimmer versys cocr heads tend to be a more common source of cobalt liberation via taper corrosion.On (b)(6) 2016, her urine cobalt level was 10 mcg/l.On (b)(6) 2017, her whole blood level was 5.1 mcg/l and urine level was 25 mcg/l.On (b)(6) 2018, her whole blood cobalt level was 4.0 mcg/l and urine cobalt level was 28 mcg/l.Given her age, she is undergoing cobalt chelation with n-acetyl cysteine in lieu of attempting revision surgery.On (b)(6) 2020, her blood cobalt level was 3.4 mcg/l and her urine cobalt level was 21 mcg/l.Fda safety report id# (b)(4).

• Brand Name: ZIMMER COCR HEAD FOR A FIBER METAL TAPER VERSYS STEM (12/14 TAPER)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V. ; warsaw IN
• MDR Report Key: 9695296
• MDR Text Key: 179105334
• Report Number: MW5092931
• 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
• 2 Devices were Involved in the Event: 1 2

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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 63