• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET METAL ON METAL HIP IMPLANT PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT Back to Search Results
Model Number CUP (44 X -6) AND 7.5 TAPER LOCK
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Dyspnea (1816); Swollen Lymph Nodes (2093); Heart Failure (2206); Toxicity (2333); Test Result (2695)
Event Date 01/25/2020
Event Type  Injury  
Event Description
Patient visited local hospital on (b)(6) 2020 due to shortness of breath she had been experiencing for 3 weeks. Ct scan revealed fluid around the heart. Lung scan revealed enlarged lymph nodes. After transfer to tertiary hospital, lvef was measured at 30% and patient was diagnosed with stage 4 heart failure. No arterial blockages were found. Advanced heart failure regimes were started with iv dobutamine and lisex. Possible causes of the heart failure from amyloidosis and sarcoidosis were ruled out based on results of heart and lung biopsies. Cobalt level was tested due to patient¿s bilateral hip replacements. Lab results showed a cobalt level of 121 mcg/l. Results from a second blood test confirmed elevated chromium levels as well (i believe it was 45 mcg/l). Subsequent mri showed a pseudotumor and fluid around the patient¿s left hip implant. Following confirmation of cobalt and chromium metallosis, a successful hip revision surgery was performed on (b)(6) 2020, replacing the metal ball with a ceramic ball and plastic liner. Patient continues require iv dobutamine and a daily diuretic for advanced heart failure and remains in the hospital as of (b)(6) 2020. I don't know the exact date of the second cobalt+chromium test, but it was a little over a week after the first cobalt measurement was taken. The second cobalt+chromium results are recalled from my memory because i don't have a copy on hand of the results. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMETAL ON METAL HIP IMPLANT
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT
Manufacturer (Section D)
ZIMMER BIOMET
MDR Report Key9775210
MDR Text Key181940468
Report NumberMW5093429
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/27/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCUP (44 X -6) AND 7.5 TAPER LOCK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/28/2020 Patient Sequence Number: 1
-
-