MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER COCR HEAD FOR M/L TAPER; PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER, POROUS UNCEMENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Atrial Fibrillation (1729); Emotional Changes (1831); Fall (1848); Fatigue (1849); Hearing Loss (1882); Visual Impairment (2138); Toxicity (2333); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 03/14/2017

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2010, she received a left total hip arthroplasty.Components are zimmer m/l taper kinective stem with an anteverted extended offset - 4 neck and 36mm +0 chrome-cobalt head with a size 56 trilogy spiked cup and 36mm inside diameter longevity liner.On (b)(6) 2017, her urine cobalt was 6.7 mcg/l and whole blood cobalt was 2.8 mcg/l.On (b)(6) 2017, her serum / plasma cobalt level was 2.6 mcg/l and urine cobalt level was 9.9 mcg/l.On (b)(6) 2018, serum / plasma chromium level was 2.5 mcg/l and the serum plasma cobalt level was 4.2 mcg/l.Beginning in about 2016, she started noticing progressive memory and cognitive problems, her depressive mood disorder became worse, her pain tolerance was dulling, she developed sleep disorder, fatigue, hearing and vision have gotten worse.She has a pacemaker implanted in 2016, and she had been experiencing atrial fibrillation around 2012.Fdg pet brain scan results with neuro q analysis were consistent with chronic toxic encephalopathy.On (b)(6) 2017, she took a fall and sustained a left pubic rami fracture.Plain films from after the fracture were compared to those made in 2014 are notable for some impaction of the left acetabular component in association with her left root of pubic rami fracture, but there appears to be minimal change in position and no evidence of outright loosening.Comorbidity is follicular lymphoma diagnosed in 2008 that began in the abdomen.She also has bilateral prosthetic knees which consist of cobalt chrome components.Fda safety report id# (b)(4).

• Brand Name: ZIMMER COCR HEAD FOR M/L TAPER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 9720799
• MDR Text Key: 180101421
• Report Number: MW5093029
• Device Sequence Number: 1
• Product Code: LPH
• 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: 02/12/2020

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: 02/14/2020
• 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
• Patient Age: 68 YR
• Patient Weight: 78