BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 24656409 · Received March 20, 2026

    Report

    Report Number
    1644408-2026-00463
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 20, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    OQG
    UDI-DI
    00888912100588
    PMA / PMN Number
    K130365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED "(DISLOCATION)". THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 7 YEARS AND 2 MONTHS APART. ITEM NUMBER: 933-32-750 ITEM DESCRIPTION: LINER 20 DEG HOODED-NEU, MP6, HXE-PLUS, 32MM. LOT NUMBER: UNKNOWN. PART REVISION: NA. PRODUCT TYPE: HIP. MANUFACTURER DATE: UNKNOWN. EXPIRATION DATE: UNKNOWN. THIS INVESTIGATION IS LIMITED IN SCOPE AS ONLY PARTIAL INFORMATION WAS PROVIDED TO DJO SURGICAL - AUSTIN FOR REVIEW. THE REVISED ITEMS WERE NOT RETURNED FOR EXAMINATION AND THE ITEM AND OR LOT NUMBERS WAS NOT PROVIDED. TO ADEQUATELY INVESTIGATE THIS EVENT, THE PART AND LOT NUMBERS ARE NECESSARY. IF THIS INFORMATION IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. CUSTOMER COMPLAINT HISTORY OF THE REPORTED ITEMS SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SURGEON PERFORMED THIS REVISION TO REMEDY THE PATIENT'S CONDITION. THIS COMPLAINT WILL BE CLOSED PENDING RECEIPT OF ADDITIONAL INFORMATION. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717096 DJO SURGICAL LINER 20 DEG HOODED-NEU, MP6, HXE-PLUS, 32MM OQG ENCORE MEDICAL L.P. UNKNOWN 00888912100588

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other 400-32-800 LOT: UNKNOWN.