BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AXLE

    MDR report key: 11415384 · Received March 4, 2021

    Report

    Report Number
    0001825034-2021-00632
    Event Type
    Injury
    Date Received
    March 4, 2021
    Date of Event
    February 4, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304002487
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE UNDER THIS FILE, BUT REPORTED UNDER (B)(4). THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE UNDER THIS FILE, BUT REPORTED UNDER (B)(6). THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 150476 - OSS POLY TIBIAL BUSHING - 545940; 150477 - OSS POLY FEMORAL BUSHINGS - 354010; 150493 - OSS REINFORCED YOKE - 933270; 150410 - OSS TIBIAL POLY BEARING 12MM - 581070; 150478 - OSS POLY LOCK PIN - 794330; 150425 - OSS MOD TIB BASEPLATE 83MM - 978210; 150362 - OSS CEMENTED IM STEM 13MMX90MM - 178750. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-00631, 0001825034-2021-00634, 0001825034-2021-00635, 0001825034-2021-00636, 0001825034-2021-00637, 0001825034-2021-00638, 0001825034-2021-00639.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY THREE DAYS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313095 OSS AXLE PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 469410 00880304002487

    Patients

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