BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL RLC 10DEG 36MM SZ24

    MDR report key: 3140749 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01754
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE DUE TO THE CUP WAS NOT RETURNED WHICH PREVENTS A DEFINITIVE CAUSE FROM BEING DETERMINED. 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/OR 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 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01754 / 01755).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO UNKNOWN REASONS. THE BIOMET HEAD, STEM AND LINER WERE REMOVED AND REPLACED WITH BIOMET PRODUCT. DURING THE PROCEDURE, THE LINER WOULD NOT LOCK INTO THE CUP. THE SURGEON ATTEMPTED TO LOCK THE LINER INTO THE CUP WITH DIFFERENT LOCKING RINGS. AS A RESULT, THE SURGEON UTILIZED ANOTHER LINER THAT LOCKED INTO PLACE AND THERE WAS A GREATER THAN THIRTY MINUTE DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242283 ARCOMXL RLC 10DEG 36MM SZ24 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 131710

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R