BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT LIP-LOC ACETABULAR LINER 28 MM NEUTRAL / HI-WALL

    MDR report key: 1901420 · Received November 17, 2010

    Report

    Report Number
    1825034-2010-00533
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 12, 2009
    Report Date
    October 18, 2010
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    K921274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 7 STATES: "PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC OR POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID. IT HAS BEEN REPORTED THAT THIS WEAR DEBRIS MAY INITIATE A CELLULAR PROCESS RESULTING IN OSTEOLYSIS OR IT MAY BE PRESENT AS A RESULT OF LOOSENING OF THE IMPLANT". THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(6) 2010. 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 SUBMITTED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 1999. PATIENT REPORTED THAT SHE RETURNED TO THE SURGEON AFTER FEELING UNUSUAL MOVEMENT OF THE HIP, AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2009. THE OPERATIVE REPORT NOTED OSTEOLYSIS PRESENT AROUND THE IMPLANTS. THE IMPLANTS WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT LIP-LOC ACETABULAR LINER 28 MM NEUTRAL / HI-WALL PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 800540

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R