BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA PROTR.LINER ØINT 36MM #L

    MDR report key: 9544811 · Received January 3, 2020

    Report

    Report Number
    3008021110-2019-00150
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 10, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY THE CHECK OF THE DHRS, NO PRE-EXISTING ANOMALY WAS FOUND ON THE 55 LINERS PLACED ON THE MARKET WITH THE SAME LOT NUMBER (1920249). NO OTHER COMPLAINT RECEIVED ON THIS LOT. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING THE SURGERY PERFORMED ON (B)(6) 2019, SOON AFTER THE IMPACTION OF THE LINER (CODE 5886.51.260, LOT 1920249), THE SURGEON NOTED THAT IT WAS UNSTABLE INSIDE THE ACETABULAR CUP. HE THEN REMOVED THE LINER FROM THE CUP AND NOTICED THAT THE TITANIUM CAP HAD MOVED FROM ITS CORRECT POSITION ON THE TOP OF THE LINER PEG. THE CAP WAS PROMPTLY RECOVERED BY THE SURGEON, WHO IMPLANTED ANOTHER AVAILABLE LINER WITHOUT ANY FURTHER ISSUE. THE PROBLEM DID NOT CAUSE PROLONGED SURGICAL TIME, NOR OTHER CONSEQUENCES FOR THE PATIENT. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12309 DELTA PROTR.LINER ØINT 36MM #L PROTRUDED LINER (UHMWPE X-LIMA + TI6AL4V) I.D. 36MM - SIZE LARGE LPH LIMACORPORATE S.P.A. 5886.51.260 1920249

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability