BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM TAPER INSERT

    MDR report key: 6616484 · Received June 6, 2017

    Report

    Report Number
    0001825034-2017-03665
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    January 7, 2016
    Report Date
    January 19, 2018
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED DUE TO OPERATIVE NOTES RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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

    (B)(4). IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 157444 M2A MAGNUM MODULAR HD 053540; US157850 M2A-MAGNUM PF CUP 50ODX44ID 690670; 21-103202 TAPERLOC HA/PC 7.5MM T1 562390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-00529.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP WAS REVISION APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO PAIN. MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED DUE TO INTRACTABLE PAIN AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, CORROSION WAS NOTED ON THE TRUNNION; HOWEVER, THERE WAS NO EVIDENCE OF METALLOSIS OR STAINED TISSUE. THE FEMORAL HEAD WAS REMOVED AND REPLACED AND A POLYETHYLENE LINER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395130 M2A-MAGNUM TAPER INSERT PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 110870

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R