BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT FLAT PE HC LINER Ø32/E

    MDR report key: 5446928 · Received February 19, 2016

    Report

    Report Number
    3005180920-2016-00051
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Date of Event
    January 21, 2016
    Report Date
    May 20, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 29 JANUARY 2016 AND INCLUDES: THERE WAS NOT ANY ADDITIONAL PATIENT HARM. BATCH REVIEW PERFORMED ON 15 FEBRUARY 2016. LOT 134681: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2013. EXPIRATION DATE: 2018-11-30. 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. MPACT ACETABULAR SHELL Ø52 TWO-HOLES, CODE 01.32.152DH, LOT. 153111 (K132879). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 SEPTEMBER 2015. EXPIRATION DATE: 2020-08-31. 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. ON FEB 18, 2016 THE QC MANAGER PROVIDED THE REPORT OF THE METROLOGICAL ANALYSIS PERFORMED ON THE LINER. ACCORDING TO THIS REPORT, THE DOCUMENTAL INVESTIGATION CONFIRMED THAT THE DEVICE HAS BEEN PRODUCED ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. AS REGARDS THE DIMENSIONAL CONTROL AFTER COMPLAINT, HE REPORTED A TABLE WITH ALL THE VALUES MEASURED AND SPECIFIED THAT THE SPECIFICATIONS FOUND OUT OF TOLERANCE WERE DUE TO PLASTIC DEFORMATION GENERATED DURING THE ATTEMPTS TO FIT THE LINER IN THE CUP AND DURING ITS EXTRACTION. ON 16 FEBRUARY 2016 THE R&D PROJECT MANAGER ANALYSED THE RETURNED IMPLANT WITH THE FOLLOWING COMMENTS: OBSERVING THE LINER SOME SCRATCHES CAN BE SEEN ON BOTH THE EXTERNAL CONICAL SURFACE AND THE BOTTOM OF IT: THAT COULD BE DUE TO BOTH THE ATTEMPTS MADE TO IMPACT THE LINER INTO THE SHELL AND THE EXTRACTION OF IT FROM THE SHELL. NO ANOMALIES WERE FOUND RELATED TO THE LOT INVOLVED IN THE CLAIM (SEE THE 'BATCH REVIEW'). AFTER QC ANALYSIS, HE ADDED THAT: THE DIMENSIONAL CONTROLS ON THE RETURNED LINER SHOWED THAT SOME SPECIFICATIONS REQUIRED FOR THE COUPLING BETWEEN LINER AND SHELL WERE SLIGHTLY NOT CONFORMING TO THE DRAWINGS; THAT COULD BE DUE TO THE TRIALS MADE TO IMPACT THE LINER INTO THE SHELL. ANYWAY THE QUOTES NOT CONFORMING ARE SLIGTLY SMALLER THAN THE LOWER TOLERANCES: THAT SHOULD NOT IMPEDE THE COUPLING BETWEEN LINER AND SHELL, BUT SLIGTHLY REDUCE THE HOLDING STABILITY OF THE LINER INTO THE SHELL. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT. ON 19 FEB 2016 THE MEDICAL AFFARIS DIRECTOR FURTHER COMMENTED AS FOLLOWS: NO CLINICAL INVESTIGATION CAN BE CARRIED OUT. AS THE PRODUCTS INVOLVED ARE LONG STANDING AND VERY LARGE QUANTITIES HAVE BEEN USED, A DESIGN PROBLEM IS EXTREMELY UNLIKELY, AND IN ANY CASE IT'S NOT OBJECT OF A CLINICAL INVESTIGATION. TECHNICAL ANALYSIS SHOULD BE PERFORMED ON RETURNED DEVICES.

    Additional Manufacturer Narrative · 1

    ON 20 APRIL 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THE INITIAL REPORT. ON 04 MAY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    AT FIRST THE SURGEON FIXED MPACT SHELL WITH SCREWS INTO THE PATIENT. THEN HE TRIED TO IMPLANT THE LINER WITH THE IMPACTOR, BUT THE LINER DID NOT FIT INTO THE SHELL. HE TRIED TO IMPLANT IT FOR 3 TIMES, BUT EVENTUALLY HE WAS NOT ABLE TO FIT THE LINER. HE WASHED THE LINER AND REMOVED THE SOFT TISSUES AROUND THE IMPLANTED SHELL. MOREOVER, HE CONFIRMED THAT THE SCREW HEADS HAD NO INFLUENCE. THEN HE TRIED TO IMPLANT THE LINER AGAIN, BUT HE WAS NOT ABLE TO. HE DECIDED TO REPLACE THE LINER WITH NEW LINER AND FINALLY HE WAS ABLE TO FIT NEW LINER INTO THE SHELL. THE INVOLVED LINER WILL BE RETURNED TO MEDACTA INTERNATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104996 MPACT FLAT PE HC LINER Ø32/E FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 134681

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other