BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 1723068 · Received June 11, 2010

    Report

    Report Number
    1818910-2010-03447
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 12, 2010
    Manufacturer
    DEPUY CMW
    Product Code
    MBB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING SURGERY THE BONE CEMENT SMARTSET GENTAM 40G 309504 WAS MIXED AND USED IN THE ACETABULUM, IT HARDENED SUCCESSFULLY. THEN THE FEMUR SHAFT WAS PREPARED AND BONE CEMENT SMARTSET GENTAM 40G CATALOGUE 3095040, BATCH 3031493 WAS MIXED AND PLACED IN THE FEMUR SHAFT. AFTER 14 MINUTES, THE SURGEON TESTED THE CEMENT, BUT IT WAS STILL SOFT. AFTER ANOTHER 3 MINUTES, IS APPEARED TO HAVE HARDENED. BEFORE THE FEMUR HEAD WAS PLACED, SURGEON TIRED TO MANEUVER THE JOINT AND THE PROSTHESIS SLIPPED OUT. MORE CEMENT BONE CEMENT SMARTSET GENTAM .20 (B) (4) HAD TO BE MIXED AND APPLIED TO THE FEMUR AND ANOTHER SUMMIT SYRINGE HAD TO BE USED. SURGICAL DELAY APPROX 17 MINUTES DUE TO THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GHV GENTAMICIN 40G BONE CEMENT MBB DEPUY CMW NA 3031493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention