MAUDE Adverse Event Report: ZIMMER THE ACCOMPANYING COCR HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER CEMENTED

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

Patient Problems Emotional Changes (1831); Encephalopathy (1833); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Burning Sensation (2146); Toxicity (2333); Sleep Dysfunction (2517); Test Result (2695)

Event Date 12/14/2016

Event Type  Injury  

Event Description

Pt id: (b)(6) this is a report for the zimmer cemented heritage cocr stem, the accompanying co cr head, and the zimmer versys co cr head when paired with the m/l taper (12/14 taper stem).On (b)(6) 2009, she received a left total hip arthroplasty, component were zimmer m/l taper kinectiv size 6 stem lot # 60510206, cat# 00-7713-006-00; versys co cr size 36mm +0 femoral head lot #61138082, cat#8018-36-02, exp date (b)(6) 2018; kinectiv modular neck 12/14 taper lot # 61040850, cat# 00-7848-022-00, trilogy acetabular system spiked/porous 54mm od longevity crosslinked polyethylene liner.This patient also has a right total hip arthroplasty that was done on (b)(6) 2000 and consists of a zimmer cocr heritage stem and 28m cocr head.Immediately after her right hip surgery, she began experiencing right hip pain.She currently never lies on the right hip due to pain, which she states is getting progressively worse.She describes that it feels like there is a ¿hot brick¿ in the lateral hip area.She has also noticed some recent pain in both artificial hips when she ascends the stairs.Her heat problems began around 2005.She has history of syncope, sinoatrial node dysfunction, atrial flutter, palpitations, hypertensions, and sleep apnea.A cardiac pacemaker was implanted on (b)(6) 2014.Her cardiac issues are concerning for possible cardiac cobalt myopathy.Since 2015, she has also developed balance problems, memory issues, sleep apnea, fatigue, mood disorder, and deafness/tinnitus.On (b)(6) 2016, her urine cobalt level was 3.2 mcg/l and her blood level was 1.7 mcg/l.On (b)(6) 2019, her urine level was 3.4 mcg/l and he blood count cobalt level was 3.2 mcg/l.She tried cobalt chelation by taking oral n-acetyl cysteine 600mg three times per day, and this was only partially effective.Patient has some social issues including limited transportation, limited family support, and financial hardship, which affect her compliance.Her pacemaker contraindicated metal suppression mri, so ms ct scans were ordered, but could not be completed by patient due to scheduling conflicts and financial hardship.She did undergo an fdg pet brain scan with neuroq analysis, which showed abnormal clusters of general and focal hypometabolism in a pattern consistent with chronic toxic encephalopathy.Fda safety report id # (b)(4).

• Brand Name: THE ACCOMPANYING COCR HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER; warsaw IN
• MDR Report Key: 9706426
• MDR Text Key: 180100684
• Report Number: MW5092974
• Device Sequence Number: 5
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/10/2020
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 98