BEUDAMED
    FDA Adverse Event Injury Summary report: N

    100KGY E-POLY ACETABULAR LINERS

    MDR report key: 6471539 · Received April 7, 2017

    Report

    Report Number
    0001825034-2017-02253
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    February 24, 2017
    Report Date
    February 8, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE IMPLANTED - UNKNOWN DATE IN SPRING 2016. MEDICAL PRODUCT: UNKNOWN HEAD CATALOG#: UNKNOWN LOT#: UNKNOWN UNKNOWN STEM CATALOG#: UNKNOWN LOT#: UNKNOWN UNKNOWN CUP CATALOG#: UNKNOWN LOT#: UNKNOWN CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BIOLOX HEAD, P/N 650-1056, L/N 703410; BIMETRIC STEM, P/N X21-182311, L/N 435310; RINGLOC CUP, P/N 11-104048, L/N 116590; TAPER SLEEVE, P/N 650-1066, L/N 408680.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED AS RETURNED LINER WAS WORN. VISUAL INSPECTION SHOWS THAT THE RIM OF THE LINER IS HEAVILY DAMAGED AND A SMALL AMOUNT OF WEAR COULD BE SEEN ON THE INSIDE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY ONE YEAR POST-IMPLANTATION DUE TO WEAR. ROUTINE FOLLOW-UP REVEALED ASYMMETRIC HEAD POSITION DUE TO EITHER SURGEON ERROR OF IMPLANTATION OR PRODUCT FAILURE. THE HEAD AND LINER WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THE MODULAR HEAD AND POLY LINER WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255051 100KGY E-POLY ACETABULAR LINERS PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 588300

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R