BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM 42-50MM TPR INSRT-3

    MDR report key: 8222589 · Received January 7, 2019

    Report

    Report Number
    0001825034-2018-11559
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    December 13, 2017
    Report Date
    May 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE DEVICES REMAIN ASSEMBLED UPON RECEIPT. VISUAL INSPECTION FOUND SCRATCHING ON THE EXPOSED SURFACE OF THE INSERT. THE TAPER IS ETCHED -3. DARK DEBRIS AND SCUFFING ARE PRESENT INSIDE THE TAPER OF THE INSERT. SCRATCHING WAS OBSERVED ON THE OUTSIDE OF THE HEAD IN MULTIPLE LOCATIONS. THE HEAD IS ETCHED 42. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS CONFIRMED THROUGH REVIEW OF OP NOTES. THE OP NOTES OF THE REVISION SURGERY STATED THAT DURING THE PROCEDURE, THE COMPONENTS WERE WELL-FIXED, WELL-POSITIONED, AND STABLE. THERE WAS MILD METALLOSIS AND MILD TRUNNIONOSIS WITH FLUID COLLECTION AROUND THE HIP WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORDS FOR REPORTED COMPONENTS IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT COULD CONTRIBUTE TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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. MEDICAL DEVICES: 157442, HEAD, LOT 831010; US157848, CUP, LOT 724930; 11-104111, FEMORAL STEM, LOT 814590. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10508.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY YEARS POST IMPLANTATION DUE TO PAIN, DISCOMFORT, MILD METALLOSIS, ELEVATED IONS, AND MILD TRUNNIONOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16338 M2A-MAGNUM 42-50MM TPR INSRT-3 PROSSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 000880

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10