BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MODULAR HEAD SIZE 44MM

    MDR report key: 6384451 · Received March 7, 2017

    Report

    Report Number
    0001825034-2017-01380
    Event Type
    Injury
    Date Received
    March 7, 2017
    Date of Event
    September 26, 2016
    Report Date
    November 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: US257850 MAGNUM TRISPIKE CUP 152480, 239254 M2A MAGNUM TAPER 011050, UNKNOWN FEMORAL STEM. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 1825034-2017-01380, 0001825034-2017-01380-1, 1825034-2017-01381, 0001825034-2017-01381-1, 1825034-2017-01382, 0001825034-2017-01382-1. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-01380 / 01382).

    Description of Event or Problem · 1

    IT WAS REPORTED IN REVISION OPERATIVE NOTES THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, SYNOVITIS, AND PAIN. PSEUDOTUMORS WERE NOTED AS WELL AS SOFT TISSUE REACTION SECONDARY TO METALLOSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNSEL THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY EIGHT YEARS POST-IMPLANTATION DUE TO METALLOSIS, METAL DEBRIS, CORROSION, ELEVATED METAL ION LEVELS, PAIN AND LIMITED MOBILITY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166639 M2A-MAGNUM MODULAR HEAD SIZE 44MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 534330

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R