BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING 12MM

    MDR report key: 13002730 · Received December 14, 2021

    Report

    Report Number
    0001825034-2021-03346
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 29, 2021
    Report Date
    April 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304239388
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THE PATIENT DID NOT HAVE A PATELLA IMPLANT AND ONLY THE ARTICULAR SURFACE, AXLE AND LOCK PIN WERE REVISED. THE COMPONENTS THAT WERE REVISED ARE REQUIRED TO BE REVISED WHENEVER THE KNEE IS OPENED. THE INITIAL REPORT SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: OSS 7CM SEGMENTAL FEMORAL LT ITEM# 150355 LOT# 705500; OSS CEMENTED IM STEM 13X150 50 ITEM# 150367 LOT# 093480; OSS NON-MOD TIB PLATE LONG 67 LONG ITEM# 150420 LOT# 781270; OSS 7CM DIAHPYSEAL SEGMENT ITEM# 150466 LOT# 754400; OSS POLY TIBIAL BUSHING ITEM# 150476 LOT# 043830; OSS POLY FEMORAL BUSHINGS ITEM# 150477 LOT# 685740; OSS POLY LOCK PIN ITEM# 150478 LOT# 949700; OSS AXLE ITEM# 150480 LOT# 949700; OSS REINFORCED YOKE ITEM# 150493 LOT# 898020. 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.

    Description of Event or Problem · 0

    IT WAS DETERMINED THE PATIENT DID NOT HAVE A PATELLA IMPLANT AND ONLY THE ARTICULAR SURFACE, AXLE AND LOCK PIN WERE REVISED. THE COMPONENTS THAT WERE REVISED ARE REQUIRED TO BE REVISED WHENEVER THE KNEE IS OPENED. THE INITIAL REPORT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SIX WEEKS POST IMPLANTATION DUE TO PATELLA DISLOCATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899393 OSS TIBIAL POLY BEARING 12MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 050940 00880304239388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H SEE H10.