BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET OFFSET TIBIAL TRAY

    MDR report key: 7754664 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05863
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    July 9, 2018
    Report Date
    October 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND THAT TWO PIECES WERE REWORKED FOR OVERSPRAY ON THE TAPER PER PRODUCT DEVIATION, WHICH COULD LIKELY BE RELATED TO THE REPORTED EVENT. 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 INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: VNGD SSK PSC INTLK FML S 55 RT CATALOG # 183300 LOT # 460060 , OFFSET TIB TRAY 2.5MM ADAPTOR CATALOG # 141490 LOT # 207560 , VANGUARD (TM) DCM TIBIAL BEARING CATALOG # 183826 LOT # 467180. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISIED DUE TO TIBIAL PROSTHESIS MOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595594 BIOMET OFFSET TIBIAL TRAY KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 985260

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R