BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR IMPLANT LOCKING SCREW

    MDR report key: 3024120 · Received March 27, 2013

    Report

    Report Number
    0001825034-2013-00710
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    PK051385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00709 / 00710).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A ELBOW ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2011 TO REMOVE AND REPLACE THE SCREW AS IT HAD BACKED OUT, CAUSING THE HEAD TO DISASSOCIATE FROM THE STEM. FURTHER, IT IS RECOMMENDED THE PATIENT UNDERGO ANOTHER REVISION PROCEDURE AS THE SCREW HAS BACKED OUT AGAIN AND THE HEAD HAS DISASSOCIATED FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127199 EXPLOR IMPLANT LOCKING SCREW PROSTHESIS, ELBOW KWI BIOMET ORTHOPEDICS N/A 179360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R