BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 36MM RLC LINER HW SZ24

    MDR report key: 3425674 · Received October 23, 2013

    Report

    Report Number
    0001825034-2013-04793
    Event Type
    Injury
    Date Received
    October 23, 2013
    Date of Event
    April 29, 2008
    Report Date
    September 24, 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
    OH, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, 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." THIS REPORT IS NUMBER 11 OF 25 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2010-00591-1 / 00598-1 AND 1825034-2013-04791/04801 AND 04806 AND 04809 AND 04813/04816).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2007, DUE TO RECURRENT DISLOCATION. THE ACETABULAR COMPONENT, POLYETHYLENE LINER, FEMORAL COMPONENT AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONALLY, THE PATIENT WAS REVISED ON (B)(6) 2008, DUE TO INSTABILITY AND A PERIPROSTHETIC FEMUR FRACTURE. THE POLYETHYLENE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. THE SURGEON ALSO IMPLANTED A TROCHANTER CLAW, BOLT AND CABLE SYSTEM. THEN, ON (B)(6) 2008, PATIENT WAS REVISED DUE TO INSTABILITY AND DISLOCATION. THE MODULAR HEAD WAS REMOVED AND REPLACED. OPERATIVE NOTES STATE THE PRESENCE OF A HEMATOMA AND THAT THE SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT. ON (B)(6) 2008, THE PATIENT WAS REVISED DUE TO INFECTION. SURGEON PERFORMED IRRIGATION AND DEBRIDEMENT AND THE ACETABULAR CUP, POLYETHYLENE LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. ALSO, THE FEMORAL STEM WAS REMOVED AND REPLACED WITH A COMPETITOR CEMENT SPACER MOLD. FINALLY, ON (B)(6) 2008 PATIENT UNDERWENT A STAGE TWO REVISION WHERE THE SURGEON REIMPLANTED TOTAL HIP COMPONENTS. THE MODULAR HEAD, ACETABULAR COMPONENT AND COMPETITOR CEMENT SPACER MOLD WERE REMOVED AND REPLACED. IT IS UNKNOWN DURING WHICH PROCEDURE THE TROCHANTER CLAW AND CABLE SYSTEM WERE REMOVED AND REPLACED. A REVIEW OF RADIOGRAPHIC IMAGES REVEALED THAT THE PATIENT IS BILATERAL. THEREFORE, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. RADIOGRAPHS SHOW THE BIOMET CUP HAS MIGRATED VERTICALLY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE FOR THE PATIENT¿S RIGHT SIDE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543989 ARCOMXL 36MM RLC LINER HW SZ24 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 552670

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R