BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC ACETABULAR LINER 28MM HI-WALL

    MDR report key: 2200199 · Received August 11, 2011

    Report

    Report Number
    1825034-2011-00697
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 12, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K926107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 LATE POSTOPERATIVE COMPLICATIONS CAN INCLUDE, NUMBER EIGHT STATES, "WEAR OR DEFORMATION OF THE ARTICULAR SURFACES MAY OCCUR AS A RESULT OF EXCESSIVE LOADING". THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6), 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 IS MDR ONE OF TWO (1825034-2011-00697 THROUGH 00698) FOR THIS EVENT. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    PATIENT REPORTED UNDERGOING TOTAL HIP ARTHROPLASTY ON (B)(6), 1998. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6), 2011, DUE TO PAIN AND POLY WEAR. THE MODULAR HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGLOC ACETABULAR LINER 28MM HI-WALL PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 301790

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R