BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CONE SZ A HI 70MM

    MDR report key: 2981463 · Received February 27, 2013

    Report

    Report Number
    0001825034-2013-00412
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 3, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE COMPONENT FOUND THAT IT WAS STILL ASSEMBLED WITH THE DISTAL STEM. THE HEX SCREW WAS NOTED TO BE STRIPPED WHICH WOULD CONTRIBUTE TO THE INABILITY OF THE STEM AND CONE BODY TO DISASSEMBLE. EVIDENCE SUGGESTS THE COMPONENT WAS CONFORMING PRIOR TO USE AND STRIPPED DURING THE ASSEMBLY IN SURGERY.

    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. 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 1825034-2013-00411 / 00412). DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON IMPLANTED AN 18 X 190 STS STEM AND A TRIAL REDUCTION WAS DONE WITH AN A 80 CONE BODY WITH -6 HEAD SIZE BUT HE COULD NOT REDUCE THE LEG. THE SURGEON THEN USED A SIZE SMALLER OF THE CONE BODY AND ATTEMPTED TO FIND THE PROPER LEG LENGTH AND TENSION. AFTER MANY ATTEMPTS TO REMOVE THE CONE FROM THE STEM, THE SURGEON REMOVED THE STEM AND CONE. AS A RESULT, THE SURGEON USED A DIFFERENT SIZE STEM AND CONE TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85458 ARCOS CONE SZ A HI 70MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 119730

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R