BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A TAPER LINER

    MDR report key: 6801598 · Received August 17, 2017

    Report

    Report Number
    0001825034-2017-06465
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    January 7, 2016
    Report Date
    December 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDIAL RECORDS AND X-RAYS PROVIDED. X-RAY REVEALED THE PATIENT HAD ARTHRITIS WITH POSTOL GRIP DEFORMITY; THERE WAS A LARGE MEDIAL WALL AND INFERIOR OSTEOPHYTES. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 · 1

    (B)(4). 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. CONCOMITANT PRODUCTS: 11-163690, M2A HEAD, 351920, 15-103688, M2A SHELL, 767400, 11-103205, TAPERLOC HIP SYSTEM, 171390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 00587, 0001825034-2017-00584.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION PROCEDURE ELEVEN YEARS POST-IMPLANTATION DUE TO OSTEOLYSIS, METALLOSIS, ELEVATED METAL ION LEVELS, AND PAIN. ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE REPORT NOTED CORROSION MATERIAL WAS AROUND THE METAL-ON-METAL ARTICULATION. CORROSION WAS ALSO FOUND AROUND THE HEAD AND AROUND THE LINER CONSISTENT WITH WEAR. THE PATIENT ALSO HAD SIGNIFICANT BONE LOSS AND ASEPTIC, LYMPHOCYTE-DOMINATED VASCULITIS-ASSOCIATED LESION (ALVAL) . ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580207 M2A TAPER LINER PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 921890

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R