BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM C CEMENTED STD STEM #3

    MDR report key: 4963986 · Received July 31, 2015

    Report

    Report Number
    3005180920-2015-00166
    Event Type
    Injury
    Date Received
    July 31, 2015
    Report Date
    November 4, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103189
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05 OCTOBER 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 07 OCTOBER 2015 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON JULY 31, 2015. LOT 140787: (B)(4) STEMS MANUFACTURED AND RELEASED ON APRIL 7, 2014. NO ANOMALIES FOUND. TO DATE, (B)(4) ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR ISSUE REPORTED. CLINICAL EVAL PERFORMED ON JULY 24,2015 BY (B)(4). THE STEM APPEARS TO BE EMBEDDED IN AN UNEVEN CEMENT MANTLE. CEMENT IS REMARKABLY DEFICIENT ON ANTERIOR/PROXIMAL AND DISTAL PORTION OF THE STEM. IN THESE CONDITIONS, SINKING OF THE STEM IS A POSSIBLE COMPLICATION. WE HAVE NO INFO AS TO THE POSSIBLE CAUSE OF SUBOPTIMAL CEMENTATION, WHICH APPEARS TO BE THE ROOT CAUSE FOR REVISION. ON JULY 14, 2015, THE SALES REPORTED THAT THE PIECES WILL NOT AVAILABLE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498918 AMISTEM C CEMENTED STD STEM #3 CEMENTED FEMORAL STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1