BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SROM FEM NMH XSML 66X58W/PIN L

    MDR report key: 244777 · Received October 13, 1999

    Report

    Report Number
    1818910-1999-00169
    Event Type
    Malfunction
    Date Received
    October 13, 1999
    Date of Event
    September 15, 1999
    Report Date
    October 13, 1999
    Manufacturer
    DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO PROBLEMS: FIRST; THIS KNEE IMPLANT HAD A SMALL TEAR IN BOTH THE INNER AND THE OUTER PACKAGING; RENDERING THE IMPLANT NON-STERILE. THIS IMPLANT DID NOT ENTER THE STERILE FIELD. SECOND; THE IMPLANT PACKAGE BEARS THE LOT NUMBER SB108046. THE IMPLANT IS ETCHED D1096. AS A SIDE EVENT; FACILITY DIDN'T HAVE ANOTHER IMPLANT AND FACILITY INTENDED TO REMOVE THE POLY BUSHING AND FLASH STERILIZED THE FEMORAL. FACILITY COULDN'T GET THE POLY BUSHING 62-3684; LOT 18756. THE HOSP WILL NOT RELEASE CONTAMINATED PRODUCTS AND IT WON'T BE RETURNED. IN THE END; A DIFFERENT SIZE IMPLANT WAS USED AND THE TIME UNDER ANESTHESIA WAS EXTENDED APPROXIMATELY ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM FEM NMH XSML 66X58W/PIN L Implant TOTAL KNEE PROSTHESIS JWH DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS, INC. NA SB108046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other