BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 48

    MDR report key: 7057107 · Received November 23, 2017

    Report

    Report Number
    3005180920-2017-00693
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807879
    PMA / PMN Number
    K122911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 20 NOVEMBER 2017. LOT 172512: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 AUGUST 2017. EXPIRATION DATE: 2022-07-24. 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. VERSAFITCUP FLAT PE HC LINER Ø 32 / C, CODE 01.26.3239HCT, LOT. 172714 (K120531) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 SEPTEMBER 2017. EXPIRATION DATE: 2022-08-28. 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. ON 23 NOVEMBER 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEMS AND COMMENTED AS FOLLOWS: THE LINER WAS ANALYZED: SOME LITTLE SIGNS WERE NOTICED, BUT NO PARTICULAR BIG DAMAGES OR FEATURES WERE NOTICED. MOREOVER, AN IMPACTION TRIAL HAS BEEN DONE, CORRECTLY POSITIONING THE LINER INTO A VERSAFITCUP CC SHELL OF THE RELATED SIZE. THE PROBLEM COULD BE RELATED TO AN INCORRECT ALIGNMENT OF THE TWO AXIS (CUP AND LINER), PREVENTING THE INSERTION OF THE LINER; IN ANY CASE, IT IS NOT POSSIBLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE PE INLAY DID NOT WANT TO FIT WHEN INSERTING INTO THE CUP. THIS WAS ACHIEVED EVEN AFTER SEVERAL TESTS OF THE CUP AND THE INLAY FOR FOREIGN BODIES OR SIMILAR. A NEW INLAY WITH THE SAME SIZE WAS USED, WHICH WAS THEN PROPERLY FIT IN THE CUP. THE SURGERY COULD THEN BE SUCCESSFULLY TERMINATED WITHOUT PROBLEMS. THE CUP WAS NOT EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834355 VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 48 CEMENTLESS ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 172512 07630030807879

    Patients

    Seq Age Sex Outcome Treatment
    1 Other