BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP FLAT PE LINER Ø 28 / G

    MDR report key: 6449457 · Received March 31, 2017

    Report

    Report Number
    3005180920-2017-00150
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 3, 2017
    Report Date
    March 31, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 27 MARCH 2017. LOT 05-0701: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 AUGUST 2005. EXPIRATION DATE: 2010-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. QUADRA-H CEMENTLESS, HA COATED STEM SIZE 8 STD, CODE 01.12.028, LOT. 070663 (K082792) LOT 070663: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JUNE 2007. EXPIRATION DATE: 2012-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE SUBJECT LOT. ON 30 MARCH 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION BASED ON THE IMAGE PROVIDED BY THE REPORTER AND COMMENTED AS FOLLOWS: REVISION OF STANDARD (NON-CROSSLINKED) POLYETHYLENE LINER 9 YEARS AFTER PRIMARY CEMENTLESS THA IN A (B)(6) MAN. RADIOGRAPHIC IMAGE SHOWS THE PRESENCE OF REGIONS OF OSTEOLYSIS IN THE PROXIMAL PART OF THE FEMUR, WHICH ARE LIKELY DUE TO ACCUMULATION OF PE DEBRIS. WEAR OF POLYETHYLENE IS A POSSIBLE, LITERATURE DESCRIBED, EVENT THAT CAN OCCUR IN THE LONG-TERM AFTER PRIMARY THA. TRIBOLOGICAL PAIRINGS THAT OFFER GOOD VERY-LONG-TERM RESULTS ARE AVAILABLE AND MAY BE A PREFERRED CHOICE FOR PATIENTS VERY YOUNG AND ACTIVE (THIS PATIENT WAS (B)(6) AT THE AGE OF PRIMARY OPERATION).

    Description of Event or Problem · 1

    REVISION OF THE INLAY AND THE HEAD PLANNED DUE TO OSTEOLYSES IN PROXIMAL ZONE AND POSSIBLE WEAR OF THE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231644 VERSAFITCUP FLAT PE LINER Ø 28 / G FLAT PE LINER LZO MEDACTA INTERNATIONAL SA 05-0701

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention