BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M2A-MAGNUM 52-60MM TPR INSR +3

    MDR report key: 8195725 · Received December 26, 2018

    Report

    Report Number
    0001825034-2018-11488
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    May 6, 2018
    Report Date
    May 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY OPERATIVE NOTES. REVISION OP NOTES WERE REVIEWED AND IDENTIFIED THAT DURING THE REVISION HEAD WAS REMOVED AND WAS NEARLY COLD WELDED- TOOK EXTRA TIME TO REMOVE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 192515, ECHO POR FEM RED LAT NC 15X155, LOT 428220, 157460, M2A-MAGNUM MOD HD SZ 60MM, LOT 899620, ABX-US157866, 66OD X 60 ID MAGNUM ABX PF CUP, LOT 907690.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY, IT WAS NOTED THAT THE HEAD HAD BEEN COLD-WELDED TO THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036976 M2A-MAGNUM 52-60MM TPR INSR +3 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 221770

    Patients

    Seq Age Sex Outcome Treatment
    1