BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL

    MDR report key: 4909550 · Received July 9, 2015

    Report

    Report Number
    3005180920-2015-00144
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 10, 2015
    Report Date
    October 8, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08 SEPTEMBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DAY THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 07/28/2015 THE RETRIEVED ITEM HAVE BEEN ANALYZED BY (B)(4) PROJECT MANAGER WITH THE FOLLOWING OUTCOMES: OBSERVING THE EXPLANTED LINER ASSEMBLED WITH THE CUP, SCRATCHES, RIFT AND CUTS CAN BE SEEN ON THE LINER, PROBABLY CAUSED BY TRYING TO DISASSEMBLE IT FROM THE CUP. ON THE CUP A PORTION WITHOUT THE COATING CAN BE NOTED, PROBABLY CAUSED BY THE REMOVAL OF IT FROM THE ACETABULUM. WHILE, OBSERVING THE EXPLANTED SCREWS AND PLUG NO PARTICULAR SIGN CAN BE SEEN. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 06, 2015: LOT 132041: (B)(4) MANUFACTURED AND RELEASED ON 11 DECEMBER 2013. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON JULY 2, 2015, THE AGENT WROTE THAT: "BY EMAIL YESTERDAY I WAS INFORMED THE IMPLANT IS AVAILABLE FOR PICK UP AT THE HOSPITAL. I WILL MAKE A TRIP TODAY TO THE HOSPITAL SPECIFICALLY TO RETRIEVE THIS. I HAVE REQUESTED PREOP XRAYS FROM THE SURGEON BUT HAVE AS YET NOT RECEIVED ANY FROM HIM. WILL ASK AGAIN". ON JULY 3, 2015, THE (B)(4) MADE THE FOLLOWING ANALYSIS: NO XRAYS ARE AVAILABLE. REPORTEDLY, THE CUP HAD BEEN IMPLANTED WITH EXCESSIVE ANTEVERSION, AND HENCE RECURRENT DISLOCATION WERE TAKING PLACE. THE CUP WAS THEN EXPLANTED AND A NEW ONE REPOSITIONED. WITHOUT XRAYS, IT IS NOT POSSIBLE TO MAKE ANY COMMENT ON WHAT HAS BEEN REPORTED. IF EXCESSIVE ANTEVERSION WAS INDEED APPLIED TO FIRST IMPLANT, THIS MAY WELL BE THE ROOT CAUSE FOR FAILURE, BUT THIS STATEMENT IS BASED ON REPORTED INFO, NO DIRECT ANALYSIS WAS POSSIBLE.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445534 MPACT ACETABULAR SHELL CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention