BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 13.0

    MDR report key: 7757185 · Received August 7, 2018

    Report

    Report Number
    0001825034-2018-05800
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    December 8, 2015
    Report Date
    August 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (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. CONCOMITANT MEDICAL PRODUCTS: ITEM # UNK, HEAD, LOT # UNK; ITEM # UNK, SHELL, LOT # UNK; ITEM # UNK, LINER, LOT # UNK; ITEM # 650-1064, TAPER SLEEVE, LOT # 954440.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. BASED ON THE OP NOTES, THE FALL RESULTED IN THE BONE FRACTURE. THEREFORE, THE ROOT CAUSE FOR BONE FRACTURE CAN BE ATTRIBUTED TO PATIENT FALL. 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 THAT APPROXIMATELY 2 WEEKS POST IMPLANTATION, THE PATIENT SUFFERED A FALL ON THEIR BUTTOCKS. THE PATIENT WAS REVISED 1 WEEK LATER DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600378 TPRLC 133 MP TYPE1 PPS HO 13.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3631472

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R