BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METAL ON METAL IMPLANT

    MDR report key: 14839764 · Received June 28, 2022

    Report

    Report Number
    0009613350-2022-00347
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    September 16, 2008
    Report Date
    April 28, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    MRA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN - ITALY. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER AS THE PRODUCT IS NOT WINTERTHUR DESIGN CONTROL. THIS EVENT WILL BEEN REPORTED BY MEDWATCH FACILITY BIOMET UK LTD - 3002806535. GIVEN THIS INFORMATION THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT MOM HIP SURGERY. APPROXIMATELY NINE YEARS POST-IMPLANTATION FOLLOW UP EXAMINATIONS ALLEGEDLY RESULTED IN ELEVATED METAL ION LEVELS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER AS THE PRODUCT IS NOT WINTERTHUR DESIGN CONTROL. THIS EVENT HAS BEEN REPORTED BY MEDWATCH FACILITY BIOMET UK LTD. GIVEN THIS INFORMATION THIS MEDWATCH WILL BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029521 UNKNOWN METAL ON METAL IMPLANT UNKNOWN MRA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN
    2714533 UNKNOWN METAL ON METAL IMPLANT UNKNOWN MRA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R