BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS QUAD-SPARING TOTAL KNEE PROCEDURE HEADED SCREW

    MDR report key: 5865983 · Received August 10, 2016

    Report

    Report Number
    0001822565-2016-02730
    Event Type
    Injury
    Date Received
    August 10, 2016
    Date of Event
    July 13, 2016
    Report Date
    March 31, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. MEDICAL PRODUCT - PFJ MILLING HANDPIECE CATALOGUE #:00592704000 LOT #:12010521. THERE IS NO THERAPY DATE ASSOCIATED WITH THESE PRODUCTS AS THEY WERE MISSING AND WERE NOT USED. NOTE THAT THE ISSUE WITH PFJ MILLING HANDPIECE CATALOGUE #:00592704000 LOT #:12010521 WAS ADDRESSED IN REPORT 0001822565 - 2016 - 04358 - 1. NO PRODUCT OR TRAY WAS RETURNED. THE DEVICE HISTORY RECORDS FOR THE 00598304033, LOT # 63216721 WERE REVIEWED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR LOT #63216721. TRACKING OF THE LOANER KIT BILL OF MATERIAL IDENTIFIED THAT THE SCREWS WERE NOT ORIGINALLY BOOKED FOR THE KIT THAT WAS DISPATCHED TO THE HOSPITAL. THE REPORTER CONFIRMED THAT THE SCREWS WERE MISSING FROM THE LOANER KIT WHEN IT WAS SENT BUT THEY WERE SENT AND RECEIVED BY THE HOSPITAL AT A LATER DATE. MORE DETAILS WERE REQUESTED FROM THE THEATRICAL CARE DEPARTMENT BUT NO RESPONSE WAS OBTAINED. THIS EVENT IS CONSIDERED TO HAVE BEEN CAUSED BY A DISTRIBUTION ERROR.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A SUPPLEMENT TO CORRECT A REPORTABILITY ERROR IN THE FOLLOWING INITIAL REPORTS: 0001822565-2016-04358, 0001822565-2016-02730, 0001822565-2016-02731, 0001822565-2016-02732. THE REPORTED EVENT WAS ERRONEOUSLY SPLIT IN TWO COMPLAINTS TO SEPARATELY REPORT THE MISSING OF THE PATELLOFEMORAL MISSING HANDPIECE (0001822565-2016-04358) AND THE MISSING SCREWS (0001822565-2016-02730, 0001822565-2016-02731, 0001822565-2016-02732). THE PROPER SUBMISSION RELATED TO THE REPORTED EVENT CAN BE FOUND IN REPORT 0001822565-2016-04358-2.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY, IT WAS DISCOVERED THAT SCREWS NEEDED TO COMPLETE THE SURGERY WERE MISSING FROM THE INSTRUMENT KIT. AS A RESULT, THE SURGEON DECIDED NOT TO PROCEED WITH THE SURGERY, AND THE PATIENT WAS BROUGHT OUT FROM UNDER ANESTHESIA.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY, IT WAS DISCOVERED THAT THE PATELLOFEMORAL MILLING HANDPIECE AND SCREWS NEEDED TO COMPLETE THE SURGERY WERE MISSING FROM THE INSTRUMENT KIT. AS A RESULT, THE SURGEON DECIDED NOT TO PROCEED WITH THE SURGERY, AND THE PATIENT WAS BROUGHT OUT FROM UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517873 MIS QUAD-SPARING TOTAL KNEE PROCEDURE HEADED SCREW KNEE INSTRUMENT LXH ZIMMER, INC. N/A 63216721

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other