BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-6

    MDR report key: 15770288 · Received November 10, 2022

    Report

    Report Number
    0001825034-2022-02560
    Event Type
    Injury
    Date Received
    November 10, 2022
    Date of Event
    April 1, 2022
    Report Date
    December 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: US157852- M2A-MAGNUM PF CUP 52ODX46ID- 306340, 157446- M2A-MAGNUM MOD HD SZ 46MM- 073130, 11-103205- TAPERLOC POR LAT FMRL 11X142- 030450. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 00950, 0001825034 - 2022 - 00951, 0001825034 - 2022 - 02561. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 13 YEARS POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE, ELEVATED METAL IONS AND METALLOSIS. DURING THE REVISION SYNOVITIS WAS NOTED. THE HEAD AND ADAPTER/SLEEVE WERE EXCHANGED WITHOUT COMPLICATIONS. THE STEM AND CUP REMAINED IMPLANTED. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060059 M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 710090

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE