BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28ID SZB HEX LNR HIWALL-ARCOM

    MDR report key: 3148646 · Received June 6, 2013

    Report

    Report Number
    0001825034-2013-01853
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    December 10, 2009
    Report Date
    May 10, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 POSSIBLE ADVERSE EFFECTS, NUMBER 11 STATES, " WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THIS PATIENT (REFERENCE 1825034-2013-01852 / 01854).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 1987. SUBSEQUENTLY, REVISION PROCEDURES WERE PERFORMED ON (B)(6) 2005 AND (B)(6) 2009, DUE TO POLY WEAR AND OSTEOLYSIS, AND (B)(6) 2013, DUE TO LOOSENING. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251480 28ID SZB HEX LNR HIWALL-ARCOM PROTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 016030

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R