BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CONE PROXIMAL BODY SZ B STD 60MM

    MDR report key: 2991168 · Received March 6, 2013

    Report

    Report Number
    0001825034-2013-00464
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. BIOMET PACKAGE INSERT CONTAINS THE FOLLOWING WARNING: 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 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00463 / 00465).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION PROCEDURE OF COMPETITOR'S PRODUCT ON (B)(6) 2013. DURING THE PROCEDURE AN ARTHROTEK SCREWDRIVER FRACTURED AND ANOTHER WAS USED TO COMPLETE THE PROCEDURE WITHOUT A DELAY IN THE PROCEDURE OR INJURY TO PATIENT. FOLLOWING THE PROCEDURE, POST OP X-RAYS FOUND THE STEM TO BE MALPOSITIONED. THE PATIENT WAS TAKEN BACK TO THE O.R. TO CORRECT STEM POSITION. DURING THIS PROCEDURE, THE TAPER DISASSEMBLY TOOL CROSS THREADED WITH THE PROXIMAL BODY, CAUSING DAMAGE TO BOTH IMPLANT AND INSTRUMENT. A STEM EXTRACTOR AND SLAP HAMMER WAS THEN ATTEMPTED FOR USE TO REMOVE THE IMPLANT; HOWEVER THE SLAP HAMMER SHEARED OFF INSIDE THE EXTRACTOR. A REPLACEMENT INSTRUMENT SET WAS USED TO REMOVE THE STEM. DURING THE REMOVAL ATTEMPTS, THE CUP BECAME DISLODGED. THE PROCEDURE WAS COMPLETED BY REMOVING AND REPLACING THE CUP, PROXIMAL BODY AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96244 ARCOS CONE PROXIMAL BODY SZ B STD 60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 118530

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R