BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 BM HO 10.0

    MDR report key: 8416233 · Received March 13, 2019

    Report

    Report Number
    0001825034-2019-01182
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    March 26, 2013
    Report Date
    July 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:EP-103254, LOT NUMBER: 2278638, BRAND NAME: EXCEED ABT CUP; CATALOG NUMBER:163669, LOT NUMBER: 723273, BRAND NAME: MOD HEAD COCR STD; UNKNOWN LINER. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FEMORAL FRACTURE 12 DAYS POST IMPLANTATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212241 TPRLC 133 FP TYPE1 BM HO 10.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 2502609

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R