BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AXLE

    MDR report key: 7590595 · Received June 12, 2018

    Report

    Report Number
    0001825034-2018-03867
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    July 25, 2013
    Report Date
    January 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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: OSS TIBIAL BEARING CATALOG # 150410 LOT # 808630, OSS TIBIAL BUSHING CATALOG # 150476 LOT # 916390, OSS POLY FEMORAL BUSHINGS CATALOG # 150477 LOT # 907020, OSS POLY LOCK PIN CATALOG # 150478 LOT # 790020, OSS REINFORCED YOKE CATALOG # 150493 LOT # 945130. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-03860, 0001825034-2018-03864, 0001825034-2018-03865, 0001825034-2018-03866, 0001825034-2018-03868. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435314 OSS AXLE KNEE PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 613080 

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R