BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD -6MM NK

    MDR report key: 3130403 · Received May 24, 2013

    Report

    Report Number
    0001825034-2013-01669
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. 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 TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013, FOR AN UNKNOWN REASON. THE ACETABULAR CUP, MODULAR HEAD AND TAPER LINER WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231325 32MM M2A MOD HEAD -6MM NK PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 816120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R