BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOENIG TRIGLANGED RINGLOC + ACETABULAR COMPONENT W/LOCKRING 54MM LEFT SZ 24

    MDR report key: 2821924 · Received November 7, 2012

    Report

    Report Number
    0001825034-2012-02344
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK983035
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE CURRENT ISSUE CANNOT BE CONFIRMED AS THE PATIENT MATCHED IMPLANT REMAINED IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION HIP ARTHROPLASTY PROCEDURE ON (B)(6) 2012 TO IMPLANT A PATIENT MATCHED TRI-FLANGE COMPONENT. DURING THE PROCEDURE, THE PATIENT MATCHED IMPLANT DID NOT MEASURE LONG ENOUGH BETWEEN THE ISCHIAL AND PUBIC FLANGE. THE COMPONENT WAS IMPLANTED; HOWEVER, ONLY THE POSTERIOR-MOST HOLES ON THE COMPONENT WERE UTILIZED FOR FIXATION. THIS CAUSED A DELAY OF SIXTY MINUTES TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOENIG TRIGLANGED RINGLOC + ACETABULAR COMPONENT W/LOCKRING 54MM LEFT SZ 24 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 156620

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R