BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS AXLE

    MDR report key: 7370822 · Received March 26, 2018

    Report

    Report Number
    0001825034-2018-02200
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    January 30, 2004
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCT: UNKNOWN FEMORAL COMPONENT CATALOG # UNKNOWN LOT # UNKNOWN, OSS POLY FEMORAL BUSHINGS CATALOG # 150477 LOT # 945790, OSS TIBIAL POLY BEARING CATALOG # 150410 LOT # 026550, OSS POLY LOCK PIN CATALOG # 150478 LOT # 919100, OSS REINFORCED YOKE CATALOG # 150479 LOT # 933910. BIOMET PATELLA CATALOG # 11-150842 LOT # 652610, OSS DIAPHYSEAL SEGMENT CATALOG # 150468 LOT # 282380, OSS STEM CATALOG # 150365 LOT # 646770, OSS TIBIAL BASEPLATE CATALOG # 150423 LOT # 150700. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. 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: 0001825034-2018-02181, 0001825034-2018-02175, 0001825034-2018-02180, 0001825034-2018-02198, 0001825034-2018-02199.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED, NO VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214107 OSS AXLE PROSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 164390

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| R