BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM SYSTEM

    MDR report key: 6415457 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01646
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    January 21, 2016
    Report Date
    December 15, 2020
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE M2A-MAGNUM MOD HD SZ 50MM AND ONE M2A-MAGNUM PF CUP 56ODX50ID WERE RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE HEAD TAPER HAS A BLACK LINE AROUND THE INSIDE AND DAMAGE TO THE FACE OF THE DEVICE. THE OUTSIDE RADIUS HAS SOME SCUFFING. THE CUP HAS SCUFFING TO THE INSIDE RADIUS AND THERE IS DEBRIS ON THE OUTSIDE RADIUS. NEW ADDITIONAL INFORMATION WOULD NOT CHANGE THE PREVIOUS INVESTIGATION. 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. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE IS UNABLE TO BE DETERMINED. 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). CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT PRODUCTS: PART 157454, LOT 920780, NAME: M2A- MAGNUM MOD HEAD. PART 139266, LOT 772870, NAME: M2A- MAGNUM TPR INSERT. PART XL80320, LOT 434250, NAME: BI-METRIC STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-04025, 0001825034-2017-01646.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED IN OPERATIVE NOTE REPORTED REVISION DUE TO PAIN AND POSSIBLE ADVERSE LOCAL TISSUE REACTION TO METAL DEBRIS. DURING THE PROCEDURE, HETEROTOPIC BONE, PSEUDOCAPSULE, BROWNISH DISCOLORATION ON THE SYNOVIAL TISSUE, AND NO EVIDENCE OF METALLOSIS WAS NOTED. THE MODULAR HEAD AND ACETABULAR CUP WERE REVISED; A POLY LINER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196126 M2A MAGNUM SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 920780

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R