BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA LINERS & ACCESSORIES

    MDR report key: 25278191 · Received May 26, 2026

    Report

    Report Number
    3008021110-2026-00221
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    LPH
    UDI-DI
    08033390136099
    PMA / PMN Number
    K182099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY REVIEW OF MANUFACTURING RECORDS DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALY OR NON-CONFORMITY THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2026. PATIENT WAS DISLOCATING THE HIP ANTERIOR. PREVIOUS SURGERY OCCURRED ON (B)(6) 2026, WHEN DELTA TT PRO ACETABULAR CUP DIA48MM (PN 5553.14.482, LOT 2202752, STERILIZAZTION 2200083) AND DELTA NEUTRAL LINER MEDIUM (PN 5885.54.157, LOT 25AT28X, STERILIZATION 2500129) WERE IMPLANTED IN COMBINATION WITH UNKNOWN FMEORAL COMPONENTS. SINCE PATIENT WAS DISLOCATING THE HIP, THE ABOVE MENTIONED ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED WITH AN ACETABULAR ASSEMBLY CONSISTING OF: DELTA TT ACETABULAR CUP DIA50MM (PN 5552.15.500), DELTA DUAL MOBILITY LINER MEDION FOR MOBILE LINER DIA40 (PN 5885.09.040), DELTA MOBILE LINER (PN 5566.50.401). SURGERY WAS COMPLETED AS INTENDED. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1947. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244736 DELTA LINERS & ACCESSORIES NEUTRAL LIMAVIT LINER I.D. 32MM, SIZE MEDIUM- LPH LIMACORPORATE S.P.A 5885.54.157 25AT28X 08033390136099

    Patients

    Seq Age Sex Outcome Treatment
    1