BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL TRAY COMPONENT

    MDR report key: 8343018 · Received February 15, 2019

    Report

    Report Number
    0001825034-2019-00660
    Event Type
    Injury
    Date Received
    February 15, 2019
    Report Date
    February 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: KNE-OSS-BEARINGS-UNK; P/N: UNK, L/N: UNK; KNE-OSS-FEMORALS-UNK; P/N: UNK, L/N: UNK; KNE-OSS-OTHER-UNK; P/N: UNK, L/N: UNK; KNE-OSS-STEMS-UNK; P/N: UNK, L/N: UNK; KNE-OSS-STEMS-UNK; P/N: UNK, L/N: UNK; KNE-OSS-TIBIAL TRAYS-UNK; P/N: UNK, L/N: UNK. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03493 -1, 0001825034 - 2019 - 00656, 0001825034 - 2019 - 00657, 0001825034 - 2019 - 00658, 0001825034 - 2019 - 00659. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT KNEE ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT HAS BEEN INDICATED FOR A REVISION DUE TO UNKNOWN REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136075 OSS TIBIAL TRAY COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other