BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MAGNUM MODULAR HEAD 46MM HEAD DIAMETER

    MDR report key: 6067794 · Received October 31, 2016

    Report

    Report Number
    0001825034-2016-04316
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    October 3, 2016
    Report Date
    June 1, 2022
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CATALOG NUMBER: US157852 LOT NUMBER:147820 BRAND NAME: M2A-MAGNUM PF CUP. CATALOG NUMBER:166315 LOT NUMBER: 843580 BRAND NAME: PROGRESSIVE POR FMRL. CATALOG NUMBER: 139254 LOT NUMBER:244050 BRAND NAME: M2A-MAGNUM 42-50MM TPR. H6: COMPONENT CODE: MECHANICAL (G04) - HEAD. A M2A-MAGNUM MOD HD WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. UPON RECEIPT, THE HEAD REMAINS ASSEMBLED WITH THE INSERT. VISUAL INSPECTION FOUND DINGS ON THE RIM OF THE HEAD. A DARK GREEN-ISH DEBRIS IS PRESENT ON THE OUTER RADIUS. THE OUTER RADIUS IS ALSO SCUFFED WITH PITTING NEAR THE APEX. THE INSERT IS ETCHED "-3". THE EXPOSED SURFACE IS CHIPPED AND SCRATCHED. SCRATCHES ARE ALSO PRESENT INSIDE THE TAPER. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ABNORMALITIES. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE HEAD AND TAPER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717971 M2A MAGNUM MODULAR HEAD 46MM HEAD DIAMETER PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 231820

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Hospitalization| R