BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFCSIGMA POST FEM AUG TRL4MMS5

    MDR report key: 14253750 · Received April 29, 2022

    Report

    Report Number
    1818910-2022-07911
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Report Date
    April 29, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295240457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #:(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THAT THE TWO SZ 5 X 4MM POSTERIOR AUGMENT TRIALS ARE DAMAGED - ITEM CODE 961906. ONE HAS BEEN REPORTED BY STERIS AS DAMAGED & NOT PUT BACK ON THE SET AND THE OTHER IS AVAILABLE FOR RETURN. THE ONE ON THE SET DOESN¿T CLIP TO THE FEMORAL TRIAL AND FALLS OFF. THIS CAN BE RETURNED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY AND ANOTHER SIZE WAS USED IN PLACE OF THESE. LOT NUMBERS AREN¿T AVAILABLE. THE POST ON THE UNDERSIDE OF THE AUGMENT WAS WORN SO WOULD NO LONGER FIT INTO THE FEMORAL TRIAL SECURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438203 PFCSIGMA POST FEM AUG TRL4MMS5 KNEE INSTRUMENT : FEMORAL TRIALS HWT DEPUY ORTHOPAEDICS INC US 96-1906 10603295240457

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown