BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA-TT ACETAB.CUP

    MDR report key: 7528946 · Received May 21, 2018

    Report

    Report Number
    3008021110-2018-00034
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Report Date
    May 30, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ANOMALIES WERE FOUND ON THE 7 DELTA TT CUPS PLACED ON THE MARKET WITH LOT# 1101388 BY CHECKING THE RELATED MANUFACTURING CHART. THE MANUFACTURING CHART OF THE CAPS HAVE ALSO BEEN CHECKED WITHOUT FINDING ANY ANOMALY. WE CAN THEREFORE STATE THAT BOTH THE CUP AND THE CAPS HAD NO PRE-EXISTING DEFECT AND THAT THE CAPS HAD BEEN CORRECTLY SCREWED INTO THE CUP HOLES (SCREWING TORQUE VALID AT CAPS PRODUCTION TIME: 1.2NM). WE RECEIVED THE DELTA TT CUP INVOLVED FOR FURTHER ANALYSIS. BY A VISUAL ANALYSIS, WE COULD CONFIRM THAT THE CAP WAS STUCK INSIDE THE HOLE: A HIGH TORQUE FORCE WAS NECESSARY TO UNSCREW IT. ONCE REMOVED THE CAP, WE PERFORMED A DIMENSIONAL CHECK ON THE THREE CUP HOLES WITH THE FOLLOWING RESULTS: NO DIMENSIONAL ANOMALY FOUND THAT COULD HAVE CAUSED THIS ISSUE. A FUNCTIONAL TEST OF THE HOLES WAS ALSO PERFORMED WITH A CALIBRATED THREADED PLUG GAGE: ALL THE HOLES OF THE CUP RESULTED TO BE FUNCTIONAL. IN CONCLUSION, NO ANOMALY WAS DETECTED BY CHECKING THE DHR OF THE INVOLVED COMPONENT AND, ACCORDING TO OUR VISUAL, FUNCTIONAL AND DIMENSIONAL ANALYSIS, NO ANOMALY WAS DETECTED ON THE CUP HOLES AND ON THE CAP. NEVERTHELESS, WE COULD ASCERTAIN THAT THE FORCE REQUIRED TO REMOVE IT FROM THE HOLE WAS HIGHER THEN EXPECTED. BASED ON THE INVESTIGATION PERFORMED, A DEFINITIVE STATEMENT ON ROOT CAUSE CANNOT BE PERFORMED. PMS DATA: WE ARE AWARE OF A TOTAL OF 3 SIMILAR COMPLAINTS (INCLUDING THIS ONE, DIFFERENT LOT NUMBERS INVOLVED) ABOUT DIFFICULTIES IN UNSCREWING THE CAP FROM THE SCREW HOLES ON A TOTAL OF (B)(4) DELTA TT CUPS SOLD WORLDWIDE SINCE 2007. (B)(4). NO SPECIFIC ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO DETECT ANY FUTURE SIMILAR ISSUES.

    Description of Event or Problem · 0

    DURING HIP REVISION SURGERY, THE SURGEON WAS GOING TO INSERT BONE SCREWS IN THE APPROPRIATE SCREW HOLES OF THE DELTA TT CUP DIA.60MM JUST IMPLANTED, TO INCREASE THE STABILITY OF THE CUP. WHILE REMOVING THE SCREW HOLES COVERS, HE FACED SOME DIFFICULTIES AS THEY WERE SCREWED VERY TIGHT INTO THE HOLES. SPECIFICALLY, HE COULD NOT REMOVE THE CENTRAL SCREW COVER OF A DELTA TT CUP DIA.60MM. CONSEQUENTLY, IN THE ATTEMPT TO REMOVE THE CAP, THE CUP HAS BECOME MOBILE AND IT WAS DECIDED TO REMOVE IT AND REPLACE IT WITH A DELTA ONE TT CUP OF THE SAME SIZE AVAILABLE IN THE OR. THIS ISSUE CAUSED 20 MINUTES OF PROLONGED SURGERY TIME. SURGEON HAPPY WITH THE FINAL IMPLANT STABILITY. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    NO ANOMALIES FOUND ON THE 7 DELTA TT CUPS PLACED ON THE MARKET WITH LOT# 1101388 BY CHECKING THE RELATED MANUFACTURING CHART. ACCORDING TO OUR RECORDS, 3 OF THESE 7 DELTA TT CUPS WERE IMPLANTED, WITHOUT RECEIVING ADDITIONAL COMPLAINTS ON THEM. WE WILL SEND A FINAL MDR ONCE THE EVALUATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    DURING A HIP REVISION SURGERY, WHEN SURGEON TRIED TO INSERT BONE SCREWS TO ENSURE THE PROPER STABILITY OF THE CUP, SOME DIFFICULTIES WERE EXPERIENCED IN REMOVING THE CENTRAL SCREW COVER OF A DELTA TT CUP DIA.60MM CAUSING 20 MINUTES OF PROLONGED SURGERY TIME. ACCORDING TO THE INFO REPORTED, SCREW COVERS WERE EXTRAORDINARILY TIGHT TO BE REMOVED AND SO, APPLIED FORCES WERE ABLE TO MOVE THE ALREADY FIXED CUP. AT THE END, IT WAS DECIDED TO REMOVE THE IMPLANTED DELTA TT CUP AND REPLACE IT WITH A DELTA ONE TT CUP OF THE SAME SIZE AVAILABLE IN THE OR. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373505 DELTA-TT ACETAB.CUP DELTA-TT ACETAB.CUP (LPH - MBL) LPH LIMACORPORATE SPA 5552.15.600 1101388

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization