BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PRECOAT STEMMED TIBIAL COMPONENT

    MDR report key: 5500961 · Received March 15, 2016

    Report

    Report Number
    2648920-2016-00080
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 16, 2016
    Report Date
    February 7, 2017
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. VISUAL INSPECTION OF THE RETURNED TIBIAL COMPONENT IDENTIFIED THAT THE WORD ¿DEMO¿ WAS ETCHED ON THE PROXIMAL SURFACE OF THE PLATE. THE COMPONENT WAS SEALED IN A PLASTIC BAG WITH ONE OF THE PEEL AND STICK LABELS APPLIED TO THE BAG. A STOCK INVESTIGATION IDENTIFIED NO OTHER UNITS FROM THIS LOT WERE AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD FOR DEVIATIONS OR ANOMALIES IDENTIFIED ONE PLANNED DEVIATION DURING THE ULTRASONIC CLEANING FOR PROCESS MONITORING PARAMETERS. THIS DEVIATION WAS TO STOP THE RELEASE OF POST STERILIZED PACKAGED PRODUCTS UNTIL COMPLETION OF THE CPM TESTING RESULTS AND WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY REVIEW IDENTIFIED NO OTHER COMPLAINTS FOR THIS ISSUE FOR P/N 00-5980-037-01 AND NO OTHER COMPLAINTS FOR L/N 63176746. ANALYSIS OF THE TIBIAL COMPONENT BY THE MANUFACTURING SITE IDENTIFIED THAT THE ETCHED ¿DEMO¿ DID NOT MATCH THE FONT STYLE OR COLOR OF THE OTHER PRODUCT INFORMATION THAT WAS ETCHED ON THE UNIT. ALSO, IT DID NOT APPEAR THAT THE WORD ¿DEMO¿ WAS ETCHED USING THE SAME METHOD THAT (B)(4) USED FOR ETCHING TIBIAL PLATES (CHEMICAL ETCH). PER THE SCRAP DISPOSITION PROCEDURE, PRODUCT OR MATERIALS THAT WILL BE KEPT AS SAMPLES ARE DISPOSITIONED AS SCRAP AND THEN ARE MARKED ¿NOT FOR IMPLANT¿. REVIEW OF THE DISTRIBUTION HISTORY FOR THIS LOT IDENTIFIED THAT ALL UNITS FROM THE LOT WERE SENT TO THE (B)(4) DISTRIBUTION CENTER AND THAT ONE UNIT FROM THIS LOT WAS REQUESTED FROM (B)(4) AS A SAMPLE DEVICE. REVIEW OF THE EVENT WITH QA/RA CONTACTS FROM (B)(4) IDENTIFIED THAT THE (B)(4) FACILITY DOES NOT HAVE THE CAPABILITY TO ETCH DEVICES. IT APPEARS THAT THE DEVICE WAS ETCHED ¿DEMO¿ AFTER LEAVING ZIMMER BIOMET CONTROL AND BEING SENT TO (B)(4). AFTER ETCHING, IT APPEARS THAT ONE OF THE PEEL AND STICK LABELS WITH A BARCODE WAS APPLIED TO THE BAG. SINCE THE UNIT HAD A BARCODE, ONCE IT WAS SENT BACK TO THE (B)(4) DISTRIBUTION CENTER IT COULD BE SCANNED AND DEPLOYED TO FRANCE. THE INVESTIGATION INDICATES THAT THE TIBIAL COMPONENT AND ITS PACKAGING WERE CONFORMING WHEN RELEASED BUT THE UNIT WAS OPENED AND ETCHED ¿DEMO¿ WHILE IN THE FIELD.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE IMPLANT WAS RECEIVED AS A NON-STERILE DEMO PRODUCT IN A PLASTIC BAG INSTEAD OF AS A STERILE IMPLANT IN ITS BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156271 NEXGEN PRECOAT STEMMED TIBIAL COMPONENT JWH JWH ZIMMER, TURPEAUX INDUSTRIAL PARK 63176746

    Patients

    Seq Age Sex Outcome Treatment
    1