BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A HI CARBON HD STD NK

    MDR report key: 11595456 · Received March 31, 2021

    Report

    Report Number
    0001825034-2021-00939
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    May 2, 2018
    Report Date
    July 16, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    K003363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED THE RETURNED SHELL HAS LIP DAMAGE AS DOES THE LINER. THE HEAD HAS SCUFFING ON THE OUTSIDE RADIUS AND THERE WAS SOME BLACK DEBRIS INSIDE OF THE TAPER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL DEVICES: ITEM # 15-105044/ M2A TPR HI CARBON LNR/ LOT # 111150; ITEM # 15-103684/ M2A-T UNIV 2-HOLE SHL/ LOT # 380410; ITEM # 103533/ LOW PROFILE SCREW / LOT # 306820; ITEM # 103530/ LOW PROFILE SCREW / LOT # 21. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021 -00937, 0001825034 -2021 -00938.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT HIP REVISION SURGERY 16 YEARS POST IMPLANTATION FOR UNKNOWN REASONS. THE HEAD, SHELL, AND LINER WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496292 32MM M2A HI CARBON HD STD NK PROSTHESIS HIP KWY ZIMMER BIOMET, INC. NI 985970

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.