BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 46MM

    MDR report key: 9226568 · Received October 23, 2019

    Report

    Report Number
    0001825034-2019-04741
    Event Type
    Injury
    Date Received
    October 23, 2019
    Date of Event
    May 13, 2019
    Report Date
    April 1, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BIOMET TAPER INSERT CAT#139254 LOT#844730. BIOMET HEAD CAT#157446 LOT#843560. BIOMET CUP CAT#US157852 LOT#151290. BIOMET STEM CAT#11-103204 LOT#939100. REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS PROVIDED. REVIEW OF THE REVISION OPERATIVE NOTES CONFIRMS THAT THE PATIENT HAD RIGHT REVISION DUE TO PAIN AND ELEVATED METAL IONS. OPERATIVE NOTES STATES MODERATE SEROUS FLUID, NO PURULENT FLUID. NO CORROSION. NO WEAR OR LOOSE BODIES IN SOCKET. SCAR TISSUE EXCISED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 00322.

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED. VISUAL INSPECTION FOUND THE HEAD TO BE ASSEMBLED WITH THE TAPER INSERT UPON RECEIPT. THE OUTER RADIUS OF THE HEAD IS SCUFFED AND SCRATCHED. THE FINISH OF A PORTION OF THE OUTER RADIUS HAS BECOME HAZY AND DULL. VISUAL INSPECTION FOUND THE EXPOSED SURFACE OF THE INSERT TO BE SCRATCHED. MATERIAL HAS CHIPPED AWAY FROM AROUND ONE OF THE CIRCULAR CUT OUTS. NO DEBRIS WAS OBSERVED INSIDE THE TAPER. ADDITIONAL INFORMATION PROVIDED DOES NOT CHANGE THE ROOT CAUSE 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04740.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 10 YEARS LATER DUE TO METALLOSIS. IT WAS NOTED THE BLOOD SERUM COBALT AND CHROMIUM LEVELS WERE ELEVATED. DURING REVISION NON PURULENT SEROUS FLUID AND DISCOLORED TISSUE WAS NOTED IN THE HIP SPACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019992 M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 843560

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNK CUP CAT#NI LOT#NI| UNK LINER CAT#NI LOT#NI| UNK STEM CAT#NI LOT#NI