BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERFILL HIP

    MDR report key: 4192297 · Received October 22, 2014

    Report

    Report Number
    1644408-2014-00659
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K130099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THE RESULT OF A PATIENT JOINT DISLOCATION POST OPERATION. THE IN-VIVO SERVICE DURATION FOR THIS PRODUCT WAS LESS THAN A DAY. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE (B)(4) COMPLAINT AGAINST LOT NUMBER 190R1005 AND THE FIRST FOR DISLOCATION. NO INFORMATION WAS SUPPLIED THAT DEFINITIVELY DESCRIBED THE NATURE OR ROOT CAUSE OF THE DISLOCATION. NO OTHER CONDITIONS RELATING TO THIS EVENT COULD BE DETERMINED WITH CONFIDENCE. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT DISLOCATING POST OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674108 TAPERFILL HIP TAPERFILL STEM, STANDARD, SIZE 11 LPH ENCORE MEDICAL, L.P. 190R1005

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 932-36-260,LOT 734F1019| 400-03-363,LOT 868B1055