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

Device Problems Corroded (1131); Patient-Device Incompatibility (2682)

Patient Problems Encephalopathy (1833); Fall (1848); Failure of Implant (1924); Memory Loss/Impairment (1958); Rash (2033); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 04/16/2015

Event Type  Injury  

Event Description

Pt id: (b)(6).On (b)(6) 2012, he underwent a right total hip arthroplasty.Implant included zimmer mlt 4 so stem, converge 51mm od socket, durasul 32 liner, and a 32mm +0 cocr head.He reported a rash of the right leg rash following prosthetic hip implantation.On (b)(6) 2015, urine cobalt level was 1.2mcg/l.On (b)(6) 2015 whole blood cobalt and chromium levels were both less than 1.0 mcg/l.On (b)(6) 2017, urine cobalt level was 0.8 mcg/l and blood cobalt level was 0.4mcg/l.In 2016, he noted symptoms of relatively new memory disorder, cardiovascular and pulmonary problems, and sleep disorder.By 2018, he developed problems of unexpected falls, fine and gross motor coordination, and rest tremor of remaining left hand, and his memory problems worsened.He was concurrently taking gabapentin for neuropathic pain related to right trans-humeral amputation.Fdg pet brain scan with neuro 2 analysis showed progressive pronounced hypometabolism of the brain in a pattern consistent with chronic toxic encephalopathy, and this was verified by comparative fdg pet brain scan studies, which were made 7 month apart.On (b)(6) 2018, the right tha was revised.The cocr head was exchanged for a delta ceramic option 32mm +3.5 head.The stem trunnion and the head bore showed evidence of early mechanically assisted crevice corrosion.The posterior capsule was intact and anatomically repaired, anterior capsule was thickened with a ¿fish flesh¿ consistent with adverse reaction to metallic debris.The abduction tendons and trochanteric bursa were intact.Frozen section of right hip tissue was sent for a pathology report which noted fibrous tissue with a giant cell foreign body reaction and degenerative changes.No acute inflammation.Fda safety report id # (b)(4).

• Brand Name: ZIMMER COCR HEAD FOR 12/14 M/L TAPER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.
• MDR Report Key: 9694072
• MDR Text Key: 179293031
• Report Number: MW5092905
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 82