BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 20841426 · Received December 4, 2024

    Report

    Report Number
    1644408-2024-01838
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    March 21, 2018
    Report Date
    November 5, 2024
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LPH
    UDI-DI
    00888912083706
    PMA / PMN Number
    K974095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2024-01834; 430-97-056, S803 - DISLOCATION, REVISION SURGERY IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    CUP SHIFTED AND DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059350 DJO SURGICAL FLARED RIM SHELL, HIP, P2 COATED W/O SCREWHOLES, 56MM LPH ENCORE MEDICAL L.P. 979G1023 00888912083706

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female 010-55-025 LOT 006A1097| 010-55-030 LOT 007A1061| 010-55-040 LOT 010A1137| 400-05-004 LOT 887B1049| 935-40-256 LOT 825F1014