BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 52-60MM TPR INSRT-3

    MDR report key: 13860789 · Received March 23, 2022

    Report

    Report Number
    0001825034-2022-00598
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    November 17, 2020
    Report Date
    May 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:139266 LOT NUMBER:961790 BRAND NAME: M2A MAGNUM TPR INSRT. CATALOG NUMBER:157456 LOT NUMBER: 814560 BRAND NAME: M2A MAGNUM HEAD. CATALOG NUMBER:US157862 LOT NUMBER:315260 BRAND NAME: M2A-MAGNUM PF CUP. CATALOG NUMBER:192411 LOT NUMBER:219480 BRAND NAME: ECHO POR FMRL RED NC. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT : 0001825034-2022-00598 AND 0001825034-2022-00599. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ELEVATED METAL IONS AND ADVERSE LOCAL TISSUE REACTION APPROXIMATELY 9 YEARS POST IMPLANTATION. DURING THE REVISION THERE WAS NO SIGNIFICANT METAL DEBRIS OR STAINING, MINIMAL TISSUE NECROSIS, AND WEAKENED POSTERIOR CAPSULE. THE HEAD AND TAPER ADAPTER WERE EXCHANGED WITHOUT COMPLICATION'S. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715405 M2A-MAGNUM 52-60MM TPR INSRT-3 PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 961790

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R