BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 62MM

    MDR report key: 8264305 · Received January 21, 2019

    Report

    Report Number
    0001825034-2019-00236
    Event Type
    Injury
    Date Received
    January 21, 2019
    Date of Event
    September 26, 2018
    Report Date
    April 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. 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). CONCOMITANT MEDICAL PRODUCTS: 11-173662, M2A 38MM MOD HD STD NK, 040280, 11-103206, TAPERLOC POR LAT FMRL 12.5X145, 151700. REPORT SOURCE: LEGAL. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00235 , 0001825034-2019-00237. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED APPROX. 12 YEARS POST IMPLANTATION DUE TO METALLOSIS WITH NEAR COMPLETE DESTRUCTION OF THE POSTLATERAL CORTEX OF THE PROXIMAL FEMORAL FEMUR AND GREATER TROCHANTERIC FRACTURE. BEFORE REVISION, PATIENT HAD A FALL. IMAGING CONFIRMED THAT THE IMPACT HAD SHATTERED THE LEFT HIP BONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56851 M2A-38 CUP NON FLARED SZ 62MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 256700 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R