BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

    MDR report key: 9097832 · Received September 20, 2019

    Report

    Report Number
    3005180920-2019-00791
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    August 23, 2019
    Report Date
    October 18, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON THE 18 "OCTOBER" 2019 THE SUPPLIER REPORTED AS FOLLOW ABOUT THIS CASE: BATCH RELEASED ON DATE: 24/10/2018 N. OF PIECES RELEASED: (B)(4). ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. THIS IS THE BATCH ASSIGNED WITH REWORK ORDER FF18/0363. OTHER COMPLAINT ALREADY RECEIVED FOR THIS BATCH. THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. MEDACTA CONFIRMS THAT ONE OF THE CUPS MENTIONED IN THE COMPLAINT UNFASTENED FROM THE CUP IMPACTOR BECAUSE ITS THREAD WAS DAMAGED. MEDACTA PERFORMED A FUNCTIONAL TEST WITH ANOTHER CUP (NOT DAMAGED) AND IT WAS NOT RELEASED EVEN IF IT WAS NOT COMPLETELY HOOKED, THE DEVICE RESULTS TO BE COMPLIANT. THE ONLY DEFECT WE DETECT IN THE PICTURES SENT BY THE CUSTOMER IS THE WORN OF THE THREAD CRESTS. THE CRESTS OF THE CUP IMPACTOR THREAD BECAME SMOOTH BECAUSE IT WAS ASSEMBLED WITH A CUP THAT HAD A RUINED THREAD. THE RUINED THREAD OF THE CUP PROBABLY DIDN'T ALLOW A CORRECT SCREW (IN AXISIS) BETWEEN THE TWO DEVICES, BRINGING TO THE WORN OF CUP IMPACTOR THREAD. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. DURING THE ANALYSIS IT IS EVALUATED THAT IT IS DIFFICULT TO SCREW THE CUP WITH THE IMPACTOR. WE SIMULATED THE IMPACTION AFTER SCREWING AND THE CUP IS DISLOCATED AFTER SOME HAMMER. ANALYZING THE CUP THREAD HOLE WE FOUND THAT THE SURFACE IS SCRATCHED AND ALSO BROKEN: THIS IS THE REASON WHY THE CUP IS DISLOCATED FORM THE IMPACTOR. THE IMPACTOR INSTRUMENT IS CONFORM WITHOUT ANY VISIBLE BREAKAGE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 3 SEPTEMBER 2019: LOT 1810285: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2019. EXPIRATION DATE: 2025-04-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL PRODUCTS INVOLVED: CUP: MPACT 01.32.154DH ACETABULAR SHELL Ø54 TWO-HOLES LOT. 188870 (K132879). BATCH REVIEW PERFORMED ON 3 SEPTEMBER 2019: LOT 188870: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2019. EXPIRATION DATE: 2024-02-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. AMIS 01.15.10.0636 AMIS CUP IMPACTOR 3.0-M8 (HPF) LOT. 1855196 BATCH REVIEW PERFORMED ON 3 SEPTEMBER 2019: LOT 1855196: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-NOV-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE NO SIMILAR EVENT REPORTED ON THIS BATCH.

    Description of Event or Problem · 1

    THE SURGEON ENGAGED THE MPACT CUP 52MM WITH THE AMIS CUP IMPACTOR, AND IMPACTED THE MPACT CUP 52MM INTO THE ACETABULUM WITH THE HAMMER. THE SURGEON TRIED TO PERFORM THE RASPING AGAIN BECAUSE THE MPACT CUP 52MM WAS NOT IMPLANTED COMPLETELY. AT THAT TIME THE SURGEON REMOVED THE AMIS CUP IMPACTOR COUPLED WITH MPACT CUP 52MM FROM THE PATIENT ACETABULUM, BUT THE MPACT CUP 52MM DISENGAGED FROM THE AMIS CUP IMPACTOR AND THE IMPLANT FELL ON THE FLOOR. SINCE THERE WAS NO BACK UP IMPLANT, THE SURGEON WAS NOT ABLE TO USE THE MPACT CUP 52MM. THE SURGEON CONSIDERED THAT THE ENGAGEMENT THE AMIS CUP IMPACTOR WITH THE MPACT CUP WAS NOT ENOUGH, SO HE PERFORMED THE REAMING AGAIN AND TRIED TO IMPLANT A 54MM MPACT CUP. HE IMPACTED THE AMIS CUP IMPACTOR WITH THE HAMMER SEVERAL TIMES AND THE MPACT CUP 54MM COMPLETELY DISENGAGED FROM THE AMIS CUP IMPACTOR. HE TRIED TO IMPLANT IT MANY TIMES, BUT THIS EVENT REOCCURRED. FINALLY THE SURGEON USED THE STRAIGHT IMPACTOR FOR ALTERNATIVE. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. TOTAL SURGERY TIME WAS ABOUT 110 MINUTES. AFTER THE SURGERY THE SALES REP TRIED TO REPEAT AGAIN, BUT THE SAME EVENT DID NOT RECURRENT. THE SURGEON HAD ABOUT 50 SURGERIES EXPERIENCES WITH OUR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895260 CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 1810285 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 Other