BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø 60 TWO-HOLES

    MDR report key: 5611222 · Received April 27, 2016

    Report

    Report Number
    3005180920-2016-00186
    Event Type
    Injury
    Date Received
    April 27, 2016
    Date of Event
    March 28, 2016
    Report Date
    July 1, 2016
    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 10 JUNE 2016 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETURNED IMPLANTS AND COMMENTED AS FOLLOWS: ON THE FEMORAL HEAD MANY SCRATCHES CAN BE SEEN, PROBABLY CAUSED DURING THE REMOVAL PHASE. ON THE CUP MUCH BONE CAN BE SEEN, JUST ON A PORTION OF THE EXTERNAL SURFACE. THE LINER IS WELL-FIXED INSIDE THE CUP; SOME SCRATCHES CAN BE SEEN ON THE INTERNAL SURFACE. IT IS NOT POSSIBLE FROM THE INSPECTION OF THE IMPLANTS DETERMINE THE ROOT CAUSE OF THE EVENT. ON 24 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION SUBMITTED IN THIS REPORT AND IN THE INITIAL ONE. ON 28 JUNE 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE PATIENT HAD ALREADY UNDERGONE A REVISION OF A MEDACTA LINER (MPACT FLAT PE HC LINER Ø 32/G, CODE 01.32.3652HCT, LOT 132136). NO OTHER INFORMATION AVAILABLE CONCERNING THE FIRST REVISION. BATCH REVIEW PERFORMED ON 26 APRIL 2016. LOT 132803: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 DECEMBER 2013. EXPIRATION DATE: 2018-09-30. 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 HOODED PE HC LINER Ø 36/G, CODE 01.32.3652HCAT, LOT. 134711 (K132879) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JANUARY 2014. 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 FLAT PE HC LINER Ø 32/G, CODE 01.32.3652HCT, LOT 132136 (K103721) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND NO EVENTS HAVE BEEN REPORTED ON ITEMS OF THIS LOT. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. HE UNDERWENT A REVISION OF THE CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266729 MPACT ACETABULAR SHELL Ø 60 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 132803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention