BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT LINER FLAT PE HC LINER Ø 32/D

    MDR report key: 5343366 · Received January 5, 2016

    Report

    Report Number
    3005180920-2015-00364
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 9, 2015
    Report Date
    April 7, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIMARY SURGERY DATE: (B)(6) 2012. FIRST REVISION (MDR 2013-0101) WITH EXCHANGE OF LINER AND BALL HEAD: (B)(6) 2013. ON DEC, 16TH IT WAS COMMUNICATED THAT THE IMPLANTS WERE DISCARDED BY THE CSSD AND SO WOULDN'T HAVE BEEN RETURNED. ON 30 DEC 2015, THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THE ROOT CAUSE FOR THIS REVISION IS REPORTEDLY DEEP INFECTION WHICH CAUSED SEVERE BONE DAMAGE, AS SHOWN ON X-RAYS. NO FURTHER CLINICAL COMMENT, NO REASON TO SUSPECT RESPONSIBILITY OF IMPLANTED DEVICES. BATCH REVIEW PERFORMED ON 04 JANUARY 2016: LOT 122750: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 OCTOBER 2012. EXPIRATION DATE: 2017-08-31. 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. MPACT CUP ACETABULAR SHELL Ø 48 CODE 01.32.048DH, LOT. 092479 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2011. EXPIRATION DATE: 2016-05-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. COCR BALL HEAD 12/14 Ø 32 SIZE S CODE 01.25.021, LOT. 124666 (K072857): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JANUARY 2013. EXPIRATION DATE: 2017-12-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. QUADRA-C STEM CEMENTED STD # 1 CODE 01.12.041, LOT. 114306 (K083558): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2011. EXPIRATION DATE: 2016-10-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ON 08MAR2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 10MAR2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    THE (B)(6) PATIENT HAS HAD A LONGSTANDING INFECTION WHICH HAS PROGRESSED INTO CELLULITIS WITH AN ULCER THAT HAS APPEARED JUST DISTAL TO THE INITIAL PRIMARY WOUND. THIS HAS PROGRESSED FURTHER INTO THE BONE WHICH AS SHOWN BY THE X-RAY HAS CAUSED OSTEOLYTIC DEFECTS TO OCCUR. THE SURGEON COMPLETED A WASHOUT WITH HEAD AND LINER CHANGE A YEAR AGO (MDR 2013-00101) WHICH HAS NOT BEEN SUCCESSFUL AND HENCE TODAY EXTRACTED ALL IMPLANTS AND REPLACED THESE WITH AN ANTIBIOTIC CEMENTED STEM AND A BIPOLAR HEAD AS THE SPACERS HE HAD ON OFFER DID NOT FIT. THE SURGEON STATED THAT THIS PATIENT INITIALLY WENT REALLY WELL POST PRIMARY TOTAL BUT HAS SINCE DETERIORATED DUE TO UNHYGIENIC HABITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5389 MPACT LINER FLAT PE HC LINER Ø 32/D HIP LINER LPH MEDACTA INTERNATIONAL SA 122750

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention