BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 13791488 · Received March 17, 2022

    Report

    Report Number
    0001825034-2022-00612
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IMPLANT DATE: 2008. MEDICAL PRODUCT: VNGD ANT STAB BRG 13X67 CATALOG # 189043 LOT # 951450; BIOMET TIBIAL LOCKING BAR CATALOG # 141205 LOT # 304220 . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE REQUESTED BUT NOT RETURNED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.  MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2022-00588. NOT RETURNED BY HOSPITAL.

    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 FOURTEEN YEARS POST IMPLANTATION DUE TO INSTABILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    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
    1292244 UNKNOWN FEMORAL COMPONENT PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

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