BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFCSIGMA POST FEMAUG TRL4MM S4

    MDR report key: 12554329 · Received September 30, 2021

    Report

    Report Number
    1818910-2021-21555
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Report Date
    September 23, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWT
    UDI-DI
    10603295240396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    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.

    Description of Event or Problem · 0

    UNFORTUNATELY THE HOSPITAL NO LONGER HAVE THE ITEMS SO I¿M UNABLE TO SEND ACROSS THE LOT NUMBERS.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    TWO DAMAGED ITEMS AT KINGS MILL HOSPITAL: DAMAGED POSTERIOR AUGMENT REF 961886. NO LONGER SITS IN FEMORAL TRIAL SECURELY. WORN FEMORAL PUNCH REF 258887000. DISTAL TIP IS MIS-SHAPEN AND WORN DOWN AND NO LONGER FIT FOR PURPOSE. IDENTIFIED BY SSD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455652 PFCSIGMA POST FEMAUG TRL4MM S4 KNEE INSTRUMENT : FEMORAL TRIALS HWT DEPUY ORTHOPAEDICS INC US 96-1886 10603295240396

    Patients

    Seq Age Sex Outcome Treatment
    1