BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA TT CUP DIA.64MM

    MDR report key: 3289030 · Received August 1, 2013

    Report

    Report Number
    3008021110-2013-00013
    Event Type
    Other
    Date Received
    August 1, 2013
    Date of Event
    July 4, 2013
    Report Date
    August 1, 2013
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE DHR OF THE DELTA TT CUP AND THE BONE SCREW INVOLVED, WITHOUT FINDING ANY DIMENSIONAL ANOMALY. AS BOTH THE DEVICES REMAINED IMPLANTED, WE PERFORMED A DIMENSIONAL AND FUNCTIONAL CHECK WITH ANOTHER CUP AND BONE SCREW BELONGING TO THE SAME LOT NUMBER OF THOSE INVOLVED IN THE EVENT. THESE CHECKS CONFIRMED THE FULL COMPLIANCE OF BOTH THE DEVICES; THE BONE SCREW DOES NOT PASS THROUGH ANY OF THE 3 HOLES USED TO FIX THE CUP TO THE ACETABULUM. BASED ON THIS ANALYSIS, WE BELIEVE THAT ALSO THE CUP AND BONE SCREW USED DURING THE SURGERY ARE FULLY FUNCTIONAL. IT'S LIKELY THAT THE SURGEON BELIEVED THAT THE SCREW PASSED THROUGH THE HOLE, AS THE DIA.64 MM CUPS HAVE A HIGH THICKNESS, THEREFORE, THE BONE SCREW "SINKS" CONSIDERABLY INSIDE THE SCREW HOLE OF THE CUP BEFORE FINAL TIGHTENING. NO CORRECTIVE ACTIONS HAVE BEEN PLANNED DUE TO THIS EVENT. THIS IS THE FIRST SIMILAR CASE REPORTED, AND OUR ANALYSIS CONFIRMED THE FULL COMPLIANCE OF BOTH THE CUP AND THE BONE SCREW. LIMA CORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 1

    THIS IS AN INTRA-OPERATIVE SIGNALING OF A POSSIBLE PROBLEM WITH A DIA.64 MM DELTA TT CUP AND A BONE SCREW, OCCURRED IN (B)(6). DURING SURGERY, IT SEEMED THAT THE FIRST BONE SCREW PASSED THROUGH THE HOLE OF THE DELTA TT CUP AFTER FINAL SCREWING ON THE ACETABULAR BONE. THE SURGEON SAFETY FIXED THE CUP TO THE BONE WITH TWO OTHER BONE SCREWS, WITHOUT ANY ISSUE. THERE WAS NO PROLONGATION OF THE SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361559 DELTA TT CUP DIA.64MM LPH, MBL LPH LIMACORPORATE S.P.A. 5552.15.640 201000608

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization BONE SCREW (MODEL # 8420-15.030, LOT # 201212676)