BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT FLAT PE HC LINER Ø 36/E

    MDR report key: 5629910 · Received May 4, 2016

    Report

    Report Number
    3005180920-2016-00200
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    April 5, 2016
    Report Date
    July 27, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10 JUNE 2016 THE R&D PROJECT MANAGER ANALYSED THE RETURNED IMPLANTS: OBSERVING THE ACETABULAR LINER, SOME SCRATCHES ON BOTH THE EXTERNAL CONICAL SURFACE AND THE BORDER CAN BE NOTED. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT. ON 23 JUNE 2016 THE QC MANAGER PERFORMED A METROLOGICAL ANALYSIS OF THE INVOLVED PRODUCT AND COMMENTED AS FOLLOWS: ACCORDING TO THE DATA REPORTED, IT IS CONFIRMED THAT THE DEVICE HAS BEEN PRODUCED ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. REGARDING THE DIMENSIONAL INSPECTION OF THE RETURNED DEVICE, ALL THE VALUES MEASURED WERE ANALYZED, AND THE SPECIFICATIONS FOUND OUT-OF-TOLERANCE WERE CONFIRMED TO BE DUE TO PLASTIC DEFORMATION GENERATED DURING THE ATTEMPTS TO FIT THE LINER IN THE CUP AND DURING ITS EXTRACTION.

    Additional Manufacturer Narrative · 1

    ON 04 JULY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE PREVIOUS REPORTS. ON 27 JULY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 MAY 2016. LOT 157512: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 FEBRUARY 2016. EXPIRATION DATE: 2021-01-27. 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 Ø 52 TWO-HOLES, CODE 01.32.152DH, LOT. 153885 (K132879) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 NOVEMBER 2015. EXPIRATION DATE: 2020-11-11. 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. NOT YET RECEIVED.

    Description of Event or Problem · 1

    DURING THE PRIMARY SURGERY, THE SURGEON ATTEMPTED TO IMPACT THE LINER. THE LINER WOULD NOT FULLY SEAT. THE SURGERY WAS DELAYED A FEW MINUTES. A SECOND LINER WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. EXPLANTS ARE AVAILABLE. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286636 MPACT FLAT PE HC LINER Ø 36/E FLAT ACETABULAR LINER LPH MEDACTA INTERNATIONAL SA 157512

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other