BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50

    MDR report key: 6471545 · Received April 7, 2017

    Report

    Report Number
    3005180920-2017-00168
    Event Type
    Injury
    Date Received
    April 7, 2017
    Date of Event
    March 10, 2017
    Report Date
    April 7, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 05 APRIL 2017. LOT 147716: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 FEBRUARY 2015. EXPIRATION DATE: 2019-12-31. 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. AMISTEM H 01.18.133 HA COATED STD STEM #3 LOT. 156856 SN (B)(4), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 MARCH 2016. EXPIRATION DATE: 2021-02-20. 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. FLAT PE HC LINER Ø 36 / E, CODE 01.26.3644HCT, LOT. 156962 (K120531), (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 FEBRUARY 2016. EXPIRATION DATE: 2021-02-08. 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 THIS LOT (COMPLAINT (B)(4), MDR 2017-00045). ON 06 APRIL 2017 THE MANUFACTURER OF THE CERAMIC BALL HEAD INVOLVED IN THIS COMPLAINT PROVIDED A DOCUMENT REVIEW REPORTING AS FOLLOWS: THE COMPONENT PROPERTIES AND MICROSTRUCTURE AS OBTAINED FROM QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILISATION. DUE TO LACK OF CERAMIC PARTS FURTHER INVESTIGATION CAN NOT BE DONE.

    Description of Event or Problem · 1

    REVISION DUE TO INFECTION. ONLY THE LEFT SIDE WAS INFECTED. THE PATIENT HAD AN INFECTION WITH STAFILOCOCCUS LUGDUNENSIS. THE IMPLANTS WERE EXPLANTED AND AN CEMENT SPACER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255160 VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 50 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 147716

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention