BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 12MM

    MDR report key: 7433677 · Received April 16, 2018

    Report

    Report Number
    0001825034-2018-02802
    Event Type
    Injury
    Date Received
    April 16, 2018
    Report Date
    May 16, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 163662, 28 MM MOD HD STD NECK TP1 TAPER, 494560. THE 150476, OSS POLY TIBIAL BUSHING, 594960. THE 150478, OSS POLY LOCK PIN, 610340. THE 161034, OSS RS POLY FEM BUSHINGS SET/2, 252670. THE 11-165218, RINGLOC BI-POLAR 28 X 47 MM, 382420. 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: 0001825034-2018-02798, 0001825034-2018-02799, 0001825034-2018-02800, 0001825034-2018-02801, 0001825034-2018-02797. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS EXPERIENCING NICKEL ALLERGY THREE YEARS POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274975 OSS TIBIAL POLY BEARING 12MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 837020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other