BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-6

    MDR report key: 7305868 · Received March 1, 2018

    Report

    Report Number
    0001825034-2018-01601
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    January 4, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. A M2A MAGNUM MODULAR HEAD AND A M2A MAGNUM TAPER WERE RETURNED. VISUAL EVALUATION IDENTIFIED THE FOLLOWING: SCUFFING AND WEAR WAS FOUND ON THE HEAD. NICKS AND SCRATCHES WERE OBSERVED ON THE OUTER SPHERICAL RADIUS OF THE HEAD. GOUGING/GRINDING DAMAGE WAS NOTED AROUND ONE OF THE CIRCULAR CUT OUTS OF THE TAPER. NO OTHER DAMAGES WERE NOTED AND NO FURTHER EVALUATION COULD BE PERFORMED. THE RECEIVED PRODUCT'S EVALUATION DOES NOT CHANGE THE FINAL CONCLUSIONS OF PREVIOUS INVESTIGATION. THE ROOT CAUSE REMAINS UNKNOWN. 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 DUE TO PAIN. HEAD AND TAPER WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT MEDICAL PRODUCTS: US157854, M2A-MAGNUM PF CUP 54ODX48ID, 395820; 157448, M2A-MAGNUM MOD HD SZ 48MM, 410900; 139252, M2A-MAGNUM 42-50MM TPR INSRT-6, 481340; 11-104112, MLRY-HD POR FMRL 12X165MM, 911650; 800-1001A, GPS SINGLE KIT W/ACDA, 440020; 800-0250, BIOMET BIOLOGICS SPRAY KIT, 85043; 800-0201, GPS DUAL SPRAY APPLICATOR TIP, 84741. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01599, 0001825034-2018-01600, 0001825034-2018-01602.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED BY THE PATIENT¿S LEGAL COUNSEL THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS ALLEGEDLY EXPERIENCING PAIN. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151079 M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 481340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other