BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM RINGLOC CONSTRAINED LINER 36MM +5MM STANDARD FACE

    MDR report key: 1890055 · Received November 3, 2010

    Report

    Report Number
    1825034-2010-00499
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    March 14, 2008
    Report Date
    October 22, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    K030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    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: DO NOT MODIFY IMPLANTS. THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE IMPLANTS AND INSTRUMENTS, PRIOR TO PERFORMING SURGERY. EVALUATION OF THE RETURNED COMPONENT FOUND GROOVES ON THE SURFACE OF THE OUTER DIAMETER CONSISTENT WITH ROUGHENING FROM IMPLANTATION. THERE IS MATERIAL REMOVAL FROM THE OUTSIDE EDGE OF THE RING GROOVE. THERE ARE DEPRESSIONS IN THE SCALLOPS OF THE COMPONENT WHICH WERE LIKELY CAUSED BY INSTRUMENTATION USED DURING INSERTION OR REMOVAL. THERE IS A THIN LINE OF BURNISHING ON THE OUTSIDE EDGE OF THE CONSTRAINING RING THAT MAY HAVE BEEN CAUSED BY CONTACT OF THE CONSTRAINING RING WITH THE FEMORAL STEM. BASED ON THE EXAMINATION OF THE LINER AND REVIEW OF RELEVANT MEDICAL RECORDS, IT IS LIKELY THE DISASSOCIATION RESULTED FROM A FAILURE OF THE CEMENT INTERFACE. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH A HISTORY OF RECURRENT DISLOCATIONS UNDERWENT REVISION HIP ARTHROPLASTY ON (B)(6) 2008 WHERE THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. DURING THE REVISION PROCEDURE, THE SURGEON DEBRIDED MARKED SYNOVITIS AND A CYST FROM THE HIP JOINT. THE LINER WAS PLACED IN A WELL-FIXED ACETABULAR CUP UTILIZING A COMPETITOR'S CEMENT. THE OPERATIVE NOTES FROM THE PROCEDURE REVEAL THAT THE SURGEON "ROUGHENED" THE OUTSIDE OF THE ACETABULAR LINER PRIOR TO CEMENTING THE LINER IN THE CUP. IT IS NOT KNOWN WHEN THE WELL-FIXED ACETABULAR CUP WAS ORIGINALLY IMPLANTED. SUBSEQUENTLY, THE PATIENT UNDERWENT ANOTHER REVISION PROCEDURE ON (B)(6) 2008 DUE TO DISASSOCIATION OF THE CONSTRAINED LINER AND ACETABULAR CUP. THE LINER AND CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEDOM RINGLOC CONSTRAINED LINER 36MM +5MM STANDARD FACE PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 500910

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R