BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA-TT ACETAB.CUP Ø56 MM

    MDR report key: 8627565 · Received May 21, 2019

    Report

    Report Number
    3008021110-2019-00059
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    May 8, 2019
    Report Date
    May 21, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT#S NO PRE - EXISTING ANOMALY WAS FOUND. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    FIRST STAGE OF A SECOND REVISION SURGERY OCCURRED ON (B)(6) 2019 DUE TO INFECTION. ALL THE FOLLOWING IMPLANTS WERE REMOVED: DELTA TT ACETABULAR CUP CODE #5552.15.560, LOT #1702220, STER. 1700133; DELTA LINER CODE #5885.42.262 LOT #1880796, STER. 1800219; FEMORAL HEAD AND STEM BY ANOTHER MANUFACTURER. CLINICAL HISTORY OF THE PATIENT IS SUMMARIZED AS FOLLOWING: PRIMARY SURGERY PERFORMED ON (B)(6) 2017: A LIMA COMPETITOR'S CERAMIC FEMORAL HEAD WAS IMPLANTED TOGETHER WITH A LIMA DELTA TT ACETABULAR CUP DIA. 56MM AND A LIMA DELTA NEUTRAL LINER DIA. 40MM #LARGE. 1ST REVISION DUE TO INFECTION OCCURRED ON (B)(6) 2019. DURING REVISION, ONLY THE LIMA BIOLOX DELTA LINER DIA. 40MM #LARGE (NOT MARKED IN USA) AND THE BIOLOX FEMORAL HEAD (NOT MANUFACTURED BY LIMACORPORATE) HAVE BEEN EXPLANTED, WHEREAS THE ACETABULAR CUP WAS LEFT IN SITU. THE JOINT WAS THEN WASHED OUT AND NEW LIMA LINER OF THE SAME SIZE WAS IMPLANTED. SECOND REVISION OCCURRED ON (B)(6) 2019. BY THE ANALYSIS, BACTERIA KLEBSIELLA WAS FOUND. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421322 DELTA-TT ACETAB.CUP Ø56 MM DELTA-TT ACETAB.CUP Ø56 MM (LPH - MBL) LPH LIMACORPORATE SPA 5552.15.560 1702220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention