BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX RINGLOC MULTI HOLE ACETABULAR CUP SZ 25 WITH LOCK RING

    MDR report key: 2173844 · Received July 24, 2011

    Report

    Report Number
    1825034-2011-00596
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K070369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE RETURNED COMPONENT FOUND PATCHES OF WHAT APPEARS TO BE BONE ON MUCH OF THE POROUS METAL SURFACE. THE AREAS OF EXPOSED METAL THAT HAVE LITTLE ATTACHED BONE ARE SHINY, WHICH SUGGESTS BONE MIGHT HAVE BEEN SCRAPED OFF THOSE AREAS AT THE TIME OF IMPLANT REMOVAL. THERE IS APPARENT BONE GROWTH DESCENDING BELOW THE CUP RIM; IT IS UNKNOWN IF EXTRA BONE IN THESE AREAS COULD HAVE CAUSED THE ALLEGED PAIN. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT HIP REVISION ARTHROPLASTY ON (B)(6), 2008 DUE TO PAIN. THE PATIENT CONTINUED TO EXPERIENCE PAIN AND A SUBSEQUENT RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011. THE ACETABULAR CUP AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGENEREX RINGLOC MULTI HOLE ACETABULAR CUP SZ 25 WITH LOCK RING PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 428410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R