BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMACEM V+ BONE CEMENT INJECTABLE

    MDR report key: 18221687 · Received November 28, 2023

    Report

    Report Number
    8030965-2023-14933
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 6, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    LOD
    UDI-DI
    07611819453425
    PMA / PMN Number
    K170802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H4, H6 PRODUCT CODE: : 07.702.040S, LOT NUMBER : 3072629, RELEASE TO WAREHOUSE DATE : 14.JUNE.2009, EXPIRATION DATE : NA, SUPPLIER: NA, MANUFACTURING SITE: WERK MEZZOVICO. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE ORIF WITH THE CEMENT AND THE TFNA FOR THE FEMORAL TROCHANTERIC FRACTURE. AFTER INJECTION OF THE CEMENT IN QUESTION, THE CEMENT DID NOT GO DEEP ENOUGH AND SPREAD LIKE AN ARROWHEAD. THE CEMENT MAY HAVE LEAKED FROM THE FRACTURE AREA. IT COULD NOT BE CONFIRMED BY C ARM, SO THAT THE SURGEON WILL CONFIRM WITH CT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TRAUMACEM V+ BONE CEMENT INJECTABLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546351 TRAUMACEM V+ BONE CEMENT INJECTABLE BONE CEMENT LOD SYNTHES GMBH 3072629 07611819453425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - NAILS: TFNA