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

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).

• Brand Name: METAL ON METAL HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 9775210
• MDR Text Key: 181940468
• Report Number: MW5093429
• 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: Other
• 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 Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CUP (44 X -6) AND 7.5 TAPER LOCK
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 57