BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL BEARING

    MDR report key: 7479027 · Received May 2, 2018

    Report

    Report Number
    0001825034-2018-03107
    Event Type
    Injury
    Date Received
    May 2, 2018
    Date of Event
    April 5, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS WHICH INDICATED EXCESSIVE WEAR ALONG THE SURFACE OF THE BEARING. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 150477 OSS POLY FEMORAL BUSHINGS 2PK 324990, 150478 OSS POLY LOCK PIN 094790, 150483 OSS SEGMENTAL STACKING ADAPTER 083050, 150464 OSS 3CM DIAPHYSEL SEGMENT 792450, CP111277 OSS-K 5CM DIAPH SEG SMOOTH 792450, 178710 CPS TAPER LOCKING CAP / OSS SC 936520, 178711 CPS/OSS 5CM TPR ADAPT W/OSS SC 424030. NO COMPATIBILITY ISSUE WAS NOTED. 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 · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO WEAR APPROXIMATELY 10 YEARS POST IMPLANTATION.

    Description of Event or Problem · 0

    N.A.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: 2010. 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. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323503 OSS TIBIAL BEARING KNEE PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 356700

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R