BEUDAMED
    FDA Adverse Event Other Summary report: N

    X-ALT HIP

    MDR report key: 3772985 · Received February 12, 2014

    Report

    Report Number
    1644408-2014-00072
    Event Type
    Other
    Date Received
    February 12, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K072154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS IDENTIFIED AS INSTABILITY AFTER 9.3 MONTHS OF PATIENT USE. 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 FOR THIS PART FROM THIS LOT. THE ROOT CAUSE OF THE INSTABILITY WAS REPORTED AS THE STEM SUBSIDING. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY: DUE TO THE LINEAR STEM SUBSIDING. THE SURGEON REMOVED THE DJO STEM, HEAD AND LINER AND REPLACED THEM WITH A STRYKER STEM, HEAD, AND DJO LINER. THE ORIGINAL DJO CUP REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92846 X-ALT HIP LINER / NON-HOODED - NEUTRAL, MP 9 36MM LPH ENCORE MEDICAL, L.P. 693F1038

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 400-03-362, LOT 866B1052| 425-01-009, LOT 062C1089