BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA-TT ACETAB.CUP 52 MM

    MDR report key: 10586327 · Received September 25, 2020

    Report

    Report Number
    3008021110-2020-00073
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    September 3, 2020
    Report Date
    April 1, 2021
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR CHECK: BY CHECKING THE DHR OF THE LOT #2003240, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 53 DELTA TT CUPS PLACED ON THE MARKET WITH THE SAME LOT#. THE DHRS OF THE CAPS WERE ALSO CHECKED AND NO DEVIATION WAS DETECTED AS WELL: BASED ON THE PRODUCTION DOCUMENTS THE INVOLVED DEVICE WAS MANUFACTURED UP TO DRAWING SPECIFICATIONS. NO OTHER SIMILAR CASE REPORTED FOR CUPS WITH THE SAME LOT#. XRAYS ANALYSYS: THE XRAYS WERE NOT AVAILABLE TO BE PROVIDED TO LIMACORPORATE FOR EVALUATION. COMPONENT ANALYSIS: THE SPECIFIC COMPONENT INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO LIMACORPORATE: THE ACETABULAR CUP REMAINED IN FACT IMPLANTED AND WAS NOT REMOVED DURING THE REVISION SURGERY ON (B)(6), 2020. THE CAP WAS INSTEAD REMOVED DURING THE REVISION SURGERY, BUT IT WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE. AN ACETABULAR CUP WITH THE SAME LOT# OF THE ONE INVOLVED IN THE COMPLAINT (5552.15.520, LOT# 2003240 - STER. 2000205) WAS THEREFORE ANALYZED. A SIMULATION OF THE IMPACTION PROCEDURE WAS PERFORMED: AFTER FIXING THE DELTA TT CUP TO A POLYURETHANE BLOCK TO SIMULATE THE "IN VIVO" BEHAVIOR, THE CUP WAS IMPACTED AS PER SURGICAL TECHNIQUE. ALL THE CAPS REMAINED FIRMLY TIGHTENED EVEN AFTER THE IMPACTION: NONE OF THEM WAS LOOSE BUT WERE ALL STILL PROPERLY SCREWED IN THEIR ORIGINAL POSITION INTO THE CUP HOLES. THE FUNCTIONAL TEST DESCRIBED ABOVE WAS ALSO PERFORMED WITH A DELTA TT CUP BELONGING TO A DIFFERENT CODE/LOT# AND THE SAME RESULTS WERE OBTAINED. MOREOVER, IN THIS CASE, THE TEST WAS PERFORMED BY SIMULATING TWO DIFFERENT BONE QUALITIES (NORMAL AND SCLEROTIC), TO EXCLUDE THIS FACTOR AS POSSIBLE CONTRIBUTORY CAUSE (A SCLEROTIC BONE POTENTIALLY COULD INDUCE INCREASED VIBRATION AROUND THE CAPS OR REQUIRE HIGHER FORCES DURING THE IMPACT). IN BOTH CASES, NO ANOMALY WAS HIGHLIGHTED AFTER THE IMPACTION OF THE CUP. UNFORTUNATELY, WITHOUT THE POSSIBILITY TO ANALYZE THE SPECIFIC CUP AND/OR CAP INVOLVED, DIMENSIONAL AND FUNCTIONAL CHECKS ON THEM CANNOT BE PERFORMED TO DEEPEN THE ANALYSIS AND THUS WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE REPORTED ISSUE. BASED ON THE ANALYSES PERFORMED, IF WE ASSUME THAT THE CUP WAS IMPLANTED BY PROPERLY FOLLOWING THE SURGICAL TECHNIQUE, THERE IS NO REASON TO BELIEVE THAT THE PATIENT'S BONE QUALITY COULD BE A CONTRIBUTORY FACTOR TO THIS ISSUE. ON THE OTHER HAND, EVEN IF WE CANNOT EXCLUDE WITH ABSOLUTE CERTAINTY A SINGLE HUMAN ERROR BY A LIMA OPERATOR WHEN SCREWING THE SPECIFIC CAP AS A POSSIBLE CONTRIBUTORY CAUSE, WE CONSIDER THIS POSSIBILITY UNLIKELY AND REMOTE AS ALL THE CAPS ARE SCREWED INTO THE CUP HOLE WITH A TORQUE SCREWDRIVER, IN ORDER TO APPLY A FIXED TIGHTENING TORQUE OF 1,5NM. AT THIS STAGE, NO DEFINITIVE CONCLUSION CAN BE DRAWN ON THE CAUSE OF THE CAP LOOSENING. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURHTER SIMILAR EVENT. PMS DATA: LIMACORPORATE IS AWARE OF A TOTAL OF 6 CASES OF LOOSENING OF THE SEALING CAPS INVOLVING DELTA TT CUPS (CODES 5552.15.XXX). AMONG THESE 6 CASES, THE ONE OBJECT OF THIS REPORT IS THE ONLY ONE WHERE A REVISION SURGERY WAS NEEDED DUE TO THIS ISSUE (IN THE OTHER 5 CASES THE LOOSENING WAS DETECTED INTRA-OPERATIVELY). SPECIFIC OCCURRENCE RATE IS VERY LOW: 0,007% NO SPECIFIC CORRECTIVE ACTION PERFORMED FOR THIS CASE. AFTER BECOMING AWARE OF FEW SIMILAR EVENTS WITH DELTA CUPS, AT THE BEGINNING OF MARCH 2016 LIMACORPORATE PLANNED TO UPDATE THE CONTROL PLAN FOR ALL THE FAMILIES OF DELTA CUPS DURING THEIR MANUFACTURING PROCESS. IN THE UPDATED PLAN, ADDITIONAL FUNCTIONAL CHECKS BETWEEN CAPS AND CUP HAVE BEEN INTRODUCED DURING THE MANUFACTURING PHASES TO FULLY ENSURE THE FUNCTIONALITY OF THE DEVICES AND REDUCE THE RISK OF INTRA-OP LOOSENING OF THE CAPS. IN ADDITION, EVEN IF THE TESTS CONFIRMED THAT THE TORQUE (1.2 NM) USED TO TIGHTEN THE CAPS INTO CUP WAS SAFE AND GUARANTEES THE STABILITY OF THE CAPS INTO CUP, THE TORQUE USED TO TIGHTEN THE CAPS HAS BEEN INCREASED TO 1.5NM AS A FURTHER IMPROVEMENT. LIMACORPORATE IS AWARE OF ONLY 2 SIMILAR EVENTS INVOLVING DELTA CUPS (ALL FAMILIES) WITH LOT#S MANUFACTURED AFTER THE CORRECTIVE ACTION PERFORMED. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT AND CONFIRM THE EFFECTIVENESS OF THE PAST PERFORMED CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON 3RD SEPTEMBER 2020. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. ACCORDING TO THE INFORMATION RECEIVED, DURING PREVIOUS SURGERY, AN INTRA-OPERATIVE ISSUE HAD OCCURRED: ONE OF THE SEALING CAPS OF THE DELTA TT CUP WITH CODE 5552.15.520, LOT# 2003240 - STER. 2000205, HAD LOOSENED DURING THE IMPACTION (EVENT REGISTERED AND REPORTED TO FDA AS MFR 3008021110-2020-00072) NEVERTHELESS, THE SURGERY WAS COMPLETED WITH THE SAME CUP, BECAUSE, ACCORDING TO THE LAST INFORMATION RECEIVED, THE ISSUE WAS NOT NOTED INTRA-OPERATIVELY, BUT SOON AFTER THE SURGERY FROM THE POST-OPERATIVE XRAYS. THE REVISION SURGERY OBJECT OF THIS REPORT WAS IN FACT PERFORMED IN ORDER TO REMOVE THE CAP. NO COMPONENT WAS REMOVED DURING THIS SURGERY, ONLY THE CAP. EVENT OCCURRED IN AUSTRIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #2003240, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE 53 DELTA TT CUPS PLACED ON THE MARKET WITH THE SAME LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2020. PREVIOUS SURGERY TOOK PLACE ONE WEEK EARLIER. ACCORDING TO THE INFORMATION RECEIVED, DURING PREVIOUS SURGERY, AN INTRA-OP ISSUE HAD OCCURRED: ONE OF THE SEALING CAPS OF THE DELTA TT CUP WITH CODE (B)(4), LOT# 2003240 - STER. 2000205, HAD LOOSENED DURING THE IMPACTION (EVENT REGISTERED AND REPORTED TO FDA AS MFR (B)(4)). NEVERTHELESS, IT WAS DECIDED NOT TO REMOVE THE CAP AND CONCLUDE THE SURGERY BY IMPLANTING THE SAME CUP. THE REVISION SURGERY OBJECT OF THIS REPORT WAS PERFORMED IN ORDER TO REMOVE THE CAP. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051797 DELTA-TT ACETAB.CUP 52 MM ACETABULAR CUPS (TI6AL4V) DIA. 52MM FOR LINER SIZE MEDIUM LPH LIMACORPORATE SPA 5552.15.520 2003240

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R