BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA TC3 INSERT 10MM, SZ4

    MDR report key: 475546 · Received August 4, 2003

    Report

    Report Number
    1818910-2003-00468
    Event Type
    Injury
    Date Received
    August 4, 2003
    Date of Event
    July 11, 2003
    Report Date
    July 11, 2003
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. A DIVISION OF DEPUY ORTHOPEDICS INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE SCRUB NURSE WAS CHECKING THE PATIENT'S NOTES WITH THE IMPLANT STICKERS, SHE FOUND THAT THE STICKER FROM INSIDE THE BOX SAID IT WAS A SZ 4 12.5 MM INSERT. THE PRODUCT CODE ON THE OUTSIDE OF THE BOX WAS 960540, LOT NUMBER 22837A. THE PRODUCT CODE INSIDE THE BOX SAID 960541 WITH LOT NUMBER 21300A. THE SURGEON HAS COMMENTED THAT THE JOINT WAS TIGHT AND HAD TO BE RELAXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA TC3 INSERT 10MM, SZ4 TOTAL KNEE PROSTHESIS JWH DEPUY ORTHOPAEDICS, INC. A DIVISION OF DEPUY ORTHOPEDICS INC. NA 22837A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention