BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 24839682 · Received April 10, 2026

    Report

    Report Number
    1644408-2026-00676
    Event Type
    Injury
    Date Received
    April 10, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ENCORE MEDICAL LP
    Product Code
    LPH
    UDI-DI
    00190446309772
    PMA / PMN Number
    K190057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGENT REPORTED "REVISED LINER IN CUP". THE ACTUAL LENGTH OF IN-VIVO FOR THE ITEM LISTED IS UNKNOWN AS THE ORIGINAL SURGERY DATE WAS NOT PROVIDED OR COULD BE ESTABLISHED. ITEM NUMBER: 942-01-36G. ITEM DESCRIPTION: EMPOWR ACETABULAR SYSTEM, LINER, 10° HOODED, HXE+, 36G. 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 ITEM WAS NOT RETURNED FOR EXAMINATION AND THE ITEM AND OR LOT NUMBER WAS NOT PROVIDED. TO ADEQUATELY INVESTIGATE THIS EVENT, THE PART AND LOT NUMBER ARE NECESSARY. IF THIS INFORMATION IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. CUSTOMER COMPLAINT HISTORY OF THE REPORTED ITEM 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

    REVISED LINER IN CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451271 DJO SURGICAL EMPOWR ACETABULAR SYSTEM, LINER, 10° HOODED, HXE+, 36G LPH ENCORE MEDICAL LP 942-01-36G 00190446309772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention