BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 18MM

    MDR report key: 9962683 · Received April 15, 2020

    Report

    Report Number
    0001825034-2020-01653
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    February 4, 2014
    Report Date
    June 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 POLY TIBIAL BUSHING CATALOG # 150476 LOT # 732490, OSS POLY FEMORAL BUSHINGS CATALOG # 150477 LOT # 004280, OSS POLY LOCK PIN CATALOG # 150478 LOT # 010010, OSS REINFORCED YOKE CATALOG # 150493 LOT # 430680, OSS AXLE CATALOG # 150480 LOT # 054700, OSS NON-MOD TIB PLATE LONG 67 CATALOG # 150420 LOT # 632350, OSS 7CM SEG ELLIPT FEMORAL LT CATALOG # 150357 LOT # 598880, OSS CEMENTED IM STEM 14X150 CATALOG # 150368 LOT # 183830. 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: 0001825034-2020-01650. 0001825034-2020-01651. 0001825034-2020-01652. 0001825034-2020-01654. 0001825034-2020-01655. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASON. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425591 OSS TIBIAL POLY BEARING 18MM PROSTHESIS, KNEE KWZ ZIMMER BIOMET, INC. N/A 358070

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R