BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD

    MDR report key: 6301821 · Received February 3, 2017

    Report

    Report Number
    0001825034-2017-00416
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 3, 2017
    Report Date
    May 13, 2019
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: US157860, M2A-MAGNUM PF CUP, LOT 788180. 139268, M2A-MAGNUM 52-60MM TPR INS, LOT 536580. 13-103211, TAPERLOC POR RED/LAT 22.5X165, LOT 404250. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. REVISION OP NOTES WERE REVIEWED AND IDENTIFIED PATIENT WAS REVISED DUE TO FAILED MOM CONSTRUCT. COLLECTION OF FLUID ABOUT THE POSTERIOR AREA WITH LAX CAPSULE CONSISTENT WITH METALLOSIS. PATIENT ALSO HAD ELEVATED COBALT LEVELS WITH 5.3 UG/L (REF: 0.0-0.9) AND CHROMIUM LEVELS 5.3 UG/L (REF: 0.1-2.1). DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS 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

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

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00414 / 00416).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY TEN YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, AND ELEVATED ION LEVELS.. THE HEAD, TAPER, AND CUP WERE REVISED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY TEN YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THE HEAD, TAPER, AND CUP WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84946 M2A MAGNUM MODULAR HEAD PROSTHESIS, HIP KWS BIOMET ORTHOPEDICS N/A 955550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R