BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A ACETABULAR SYSTEM

    MDR report key: 6502942 · Received April 19, 2017

    Report

    Report Number
    0001825034-2017-02605
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    September 27, 2016
    Report Date
    April 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M2A FEMORAL HEAD, CATALOG#: 11-173665, LOT#: 183460; BI-METRIC FEMORAL STEM, CATALOG#: X180314, LOT#: 134470. IT HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET. 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: 0001825034-2016-04194 AND 0001825034-2017-02605.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY 12 YEARS POST-IMPLANTATION DUE TO PAIN AND DISCOMFORT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285286 M2A ACETABULAR SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 821070

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R