BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ROTATING HINGE KNEE PRECOAT TIBIAL COMPONENT

    MDR report key: 6023117 · Received October 12, 2016

    Report

    Report Number
    0001822565-2016-03666
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 7, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    PMA / PMN Number
    PK013385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: ZIMMER NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE, 17 MM (CATALOG# 00-5880-060-17, L/N 62398087). ZIMMER NEXGEN ROTATING HINGE KNEE FEMORAL, SIZE F, RIGHT (CATALOG# 00-5880-016-02, L/N 63240286 ). ZIMMER NEXGEN STRAIGHT LONG STEM EXTENSION 16 MM X 200 MM (CATALOG# 00-5988-011-16, L/N 62110447). ZIMMER NEXGEN PRECOAT ROTATING HINGE KNEE FEMORAL AUGMENT 5 MM POSTERIOR AUGMENT (CATALOG# 00599003601*OP9450, L/N 62627369). ZIMMER NEXGEN PRECOAT ROTATING HINGE KNEE FEMORAL AUGMENT 5 MM POSTERIOR AUGMENT (CATALOG# 00599003601*OP9450, L/N 62998836). ZIMMER NEXGEN STRAIGHT STEM EXTENSION 10 MM X 145 MM (CATALOG# 00-5988-010-10, 63198709). ZIMMER NEXGEN PRECOAT CRA/LCCK/RHK 5 MM DISTAL FEMORAL AUGMENT FOR SIZE F ONLY (CATALOG # 00-5990-036-10, LOT #: UNK). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED COMPONENTS EXHIBIT SIGNS OF BEING IMPLANTED SCRATCHED GOUGED AUGMENTS AND STEM EXTENSION ARE ASSEMBLED TO THE FEMORAL COMPONENT THE TIBIA ALSO HAS A STEM EXTENSION ASSEMBLED TO IT THE HINGE POST AND HINGE POST EXTENSION EXHIBIT DAMAGED THREADS. SURGICAL NOTE FROM THE IMPLANTATION PROCEDURE WAS PROVIDED FOR REVIEW. IT SHOWS THERE WERE NO ISSUES DURING THE SURGERY AND ALL PROCEDURE FOLLOWED PRECISELY. FINAL KNEE EXAMINATION IDENTIFIED GOOD STABILITY OF THE IMPLANTS THAT ALLOWED 110 DEGREES OF FLEXION AND FULL EXTENSION/ MOREOVER, THE IMPLANTS WAS STABLE IN BOTH FRONTAL AND SAGITTAL PLANES. FRONTAL AND LATERAL X-RAYS AFTER SURGERY COMPLETION WERE SATISFACTORY. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING FILED IN CONJUNCTION WITH THE FOLLOWING REPORTS AS THEY ARE FOR THE SAME PATIENT: 0001822565-2016-02991, 0001822565-2016-02973.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY REVISION DUE TO LOOSENING OF THE FEMORAL HINGE AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671979 NEXGEN ROTATING HINGE KNEE PRECOAT TIBIAL COMPONENT KNEE PROSTHESIS KRO ZIMMER, INC. 63229807

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R