BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SEGMENTAL DISTAL FEMORAL COMPONENT

    MDR report key: 5659244 · Received May 17, 2016

    Report

    Report Number
    0001822565-2016-01588
    Event Type
    Injury
    Date Received
    May 17, 2016
    Report Date
    January 26, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK070978
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMMER NEXGEN RHK TIBIAL PLATE CATALOG #: 00-5880-003-00 LOT #: 61762214. ZIMMER NEXGEN OFFSET STEM EXTENSION CATALOG #: 00-5988-020-13 LOT #: 61818191. ZIMMER SEGMENTAL ARTICULAR SURFACE CATALOG #: NI LOT #: NI. ZIMMER NEXGEN TM TIBIAL CONE CATALOG #: 00-5450-059-05 LOT #: 61626525. 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 4 FOR THIS PATIENT. SEE ALSO 0001822565-2016-01589-1, 0001822565-2016-01590-1, AND 0001822565-2016-01591-1 NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE STEM EXTENSION USED WITH THE TIBIAL COMPONENT IDENTIFIED NO DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL COMPONENT IDENTIFIED ONE ANOMALY DURING THE BORE, THREAD, AND DEBURR TAPER STEP (OPERATION 600) AND ONE ANOMALY DURING THE GROUP SUBCOMPONENTS STEP (OPERATION 8500). ONE UNIT WAS FOUND TO BE OUT OF TOLERANCE WHEN COMPARED TO THE OVERLAY DURING OPERATION 600. THE AFFECTED UNIT WAS SCRAPPED. THIS ANOMALY WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NINE UNITS WERE FOUND TO HAVE DISCOLORATION ON THE TAPER DURING OPERATION 8500. THE LOT WAS REWORKED FOLLOWING A STANDARD REWORK PROCESS. THIS ANOMALY WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS DEVICE IS USED FOR TREATMENT. OPERATIVE NOTES FROM THE PATIENT¿S LATEST REVISION SURGERY STATE THAT THE PATIENT WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS AND PREVIOUSLY UNDERWENT BILATERAL KNEE REPLACEMENT WITH REVISIONS ON EACH SIDE. TRIALING WITH PROVISIONALS SHOWED EQUALIZED LEG LENGTHS AND GOOD PATELLAR TRACKING. A SEGMENTAL FEMORAL COMPONENT WITH A STEM EXTENSION WAS IMPLANTED. POSTOPERATIVELY THE PATIENT WAS NOTED TO HAVE FLEXION FROM 0 TO AROUND 80 DEGREES. PER THE NEXGEN RHK PACKAGE INSERT, PAIN IS A KNOWN RISK OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    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 PATIENT IS EXPERIENCING PAIN AND IS UNABLE TO BEAR WEIGHT AFTER REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314887 ZIMMER SEGMENTAL DISTAL FEMORAL COMPONENT KNEE PROSTHESIS KRO ZIMMER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other