BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MOD HD COCR DIA28/+3MM T1

    MDR report key: 5322605 · Received December 23, 2015

    Report

    Report Number
    3002806535-2015-04185
    Event Type
    Injury
    Date Received
    December 23, 2015
    Report Date
    October 14, 2013
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. (B)(4), THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K042037. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DIMENSIONAL EVALUATION AND ROOT CAUSE COULD NOT BE DETERMINED AS A BIOLOGICAL RESIDUE COVERED THE COMPONENT OBSCURING THE BEARING SURFACE OF THE DEVICE FROM BEING EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848560 M2A MOD HD COCR DIA28/+3MM T1 PROSTHESIS, HIP KWA BIOMET UK LTD. N/A S530935

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R