MAUDE Adverse Event Report: ZIMMER/ BIOMET ZIMMER DUROM COCR METAL ON METAL HIP IMPLANT; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT

Device Problems Corroded (1131); Loose or Intermittent Connection (1371)

Patient Problems Tinnitus (2103); Toxicity (2333)

Event Type  Injury  

Event Description

Pt id: (b)(6); on (b)(6) 2006, she received a left total hip arthroplasty with a zimmer durom metal on metal implant, and the record for this operation is unavailable to us as it was done outside of dr (b)(6) practice.On (b)(6) 2010, serum cobalt level was 2.1 mcg/l.On (b)(6) 2011, serum cobalt level was 2.8 mcg/l.On (b)(6) 2012, blood cobalt level was 8.0 mcg/l and serum/plasma cobalt level was 7.7 mcg/l.On (b)(6) 2012, blood cobalt level was 8.9 mcg/l.Metal suppression mri of the left hip was made on (b)(6) 2012, and showed increased fluid about the joint itself, some of which tracks into the pelvis along the iliopsoas tendon.Plain x-rays of the left hip made in (b)(6) 2012 showed that the shell of the durom was positioned at about 80 degrees of an opening angle and no significant radiolucency.In (b)(6) of 2012, she reported episodes of tinnitus and developed new cardiovascular-type symptoms.Plain x-rays of the left hip made on (b)(6) 2012 showed a shift in the position of the left acetabular component of about 8 degrees and to a more vertical position with a halo of radiolucency about the acetabular component on both the arterior and posterior and false profile views.Due to loosening and steepening of acetabular shell and related rising cobalt levels, this implant was revised on (b)(6) 2012 by dr (b)(6).The durom shell and head with adaptor tapers was removed.The shell was quite loose, no gross metallosis, some apparent corrosion at bore of taper and trunnion of the stem and soft tissues were well preserved.New implant was a zimmer continuum socket 54mm diameter fixed with 2 screws, a longevity liner, and a 36mm +3.5 biolox delta ceramic head with taper sleeve.Pathology report of frozen section of left hip capsule and bone from acetabular reamings notably described as dense fibroconnective tissue with chronic inflammation and trabecular bone with food with foci of marrow fibrosis, respectively.Cobalt level of the left hip joint fluid was 280 mcg/l and chromium level was 750 mcg/l.On (b)(6) 2010, she received a right total hip arthroplasty with zimmer uncemented components: coverage 55 mm shell, 38mm id durasul neutral liner, 7.5mm taper standard offset stem, and a 38mm +0 cocr head.She has still retained these components in her right tha.Her cobalt level has not been elevated since revision of the left metal on metal tha.Fda safety report id# (b)(4).

• Brand Name: ZIMMER DUROM COCR METAL ON METAL HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER/ BIOMET
• MDR Report Key: 9805256
• MDR Text Key: 183110746
• Report Number: MW5093613
• Device Sequence Number: 1
• Product Code: KWA
• 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: 03/04/2020

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: 03/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1