BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP SHELL CC TRIO NO-HOLE 54

    MDR report key: 4619995 · Received March 18, 2015

    Report

    Report Number
    3005180920-2015-00038
    Event Type
    Injury
    Date Received
    March 18, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K122911
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MARCH 2015: LOT 143350: (B)(4) SHELLS PRODUCED AND RELEASED ON 22 JULY 2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR PROBLEM. LOT 100256: (B)(4) STEMS PRODUCED AND RELEASED ON 24 MARCH 2010. EXPIRATION DATE: 2015-02-28. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR PROBLEM. ON 17 MARCH 2015 WE HAVE BEEN INFORMED THAT THE EXPLANTED ITEMS WILL NOT RETURN.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185282 VERSAFITCUP SHELL CC TRIO NO-HOLE 54 ACETABULAR CEMENT LESS CUP, LZO, MEH LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1