BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL LOCKING BAR

    MDR report key: 13236935 · Received January 12, 2022

    Report

    Report Number
    0001825034-2022-00085
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    December 21, 2021
    Report Date
    April 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304009738
    PMA / PMN Number
    K063732
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD CR TIB BRG 10X71/75 CATALOG #: 183440 LOT #: 074310. VNGD CR TIB BRG 10X71/75 CATALOG #: 183440 LOT #: 229640. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED. 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 - 2021-03462.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO YEARS POST IMPLANTATION DUE TO FRACTURED LOCKING BAR. PRIOR TO SURGERY X-RAY SHOWED DISLODGED LOCKING BAR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781327 BIOMET TIBIAL LOCKING BAR PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 602670 00880304009738

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE.