BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET OFFSET TIBIAL TRAY

    MDR report key: 7751801 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05846
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 9, 2018
    Report Date
    March 6, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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, VNGD SSKPSC TIB BRG S 16X63/67 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. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2018-05848. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING REVISION PROCEDURE THE TIBIAL PROSTHESIS WAS REMOVED FROM THE PATIENT AFTER SEVERAL ATTEMPTS. THE FEMORAL AND DISTAL TIBIAL COMPONENTS WERE UNABLE TO BE REMOVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594525 BIOMET OFFSET TIBIAL TRAY KNEE PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 985260

    Patients

    Seq Age Sex Outcome Treatment
    1