BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 5775643 · Received July 7, 2016

    Report

    Report Number
    0001822565-2016-02307
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    September 6, 2015
    Report Date
    January 23, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK991581
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RETURNED, NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMMER NEXGEN TIBIAL PLATE: CATALOG #: 00-5980-037-01, LOT #: 62772488. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS IS REPORT 1 OF 2 FOR THIS PATIENT. SEE ALSO 0002648920-2016-00919-1. VISUAL INSPECTION OF THE RETURNED ARTICULAR SURFACE IDENTIFIED THAT THE DOVETAIL FEATURE WAS COMPRESSED ON BOTH SIDES. GOUGES WERE ALSO NOTED ON THE COMPONENT BACKSIDE. MEASURED DIMENSIONS WERE CONFORMING TO PRINT SPECIFICATIONS. THE TIBIAL COMPONENT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ARTICULAR SURFACE IDENTIFIED ONE ANOMALY DURING THE MILLING STEP (OPERATION 1000). ONE UNIT WAS FOUND TO HAVE THE HEIGHT OUT OF SPECIFICATION. THE AFFECTED UNIT WAS SCRAPPED AND THE REMAINING GOOD PARTS WERE ACCEPTED THROUGH NORMAL PROCESSING. THIS ANOMALY WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT IDENTIFIED ONE PLANNED DEVIATION TO HOLD PRODUCT PROCESSED THROUGH THE UPGRADE OPERATION USING EQUIPMENT (B)(4) UNTIL THE PREVENTIVE MAINTENANCE AND SUBSEQUENT TESTING THAT WAS PART OF A MAINTENANCE REQUEST (B)(4) ON THE EQUIPMENT WAS COMPLETE. THE DEVIATION ALLOWED THE PACKAGING OPERATIONS PROCESS TO CONTINUE BUT THE UNITS REMAINED ON HOLD UNTIL THE SMR WAS CLOSED. AFTER CLOSURE OF THE SMR, REQUIRED TESTING IDENTIFIED READINGS INSIDE THE INDICATED LIMITS. THIS DEVIATION WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS DEVICE IS USED FOR TREATMENT. REVIEW OF THE SIZES OF THE ARTICULAR SURFACE AND TIBIAL COMPONENT IDENTIFIED THAT THEY WERE NOT COMPATIBLE. THE ARTICULAR SURFACE WAS FOR TIBIAL COMPONENT SIZES 1 AND 2 BUT THE TIBIAL COMPONENT IMPLANTED WAS A SIZE 3. THE CAUSE OF THE COMPLAINT IS CONSIDERED TO BE USER ERROR AS THESE TWO COMPONENTS ARE NOT SIZED TO BE USED TOGETHER.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ARTICULAR SURFACE KNEE IMPLANT WAS NOT SEATING CORRECTLY. IT WAS FURTHER NOTED THAT THE ARTICULAR SURFACE AND TIBIAL COMPONENT WERE NOT COMPATIBLE, AS THEY WERE DIFFERENT SIZES. ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428808 NEXGEN LPS-FLEX ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. 62886579

    Patients

    Seq Age Sex Outcome Treatment
    1