BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CRUCIATE RETAINING PRECOAT FEMORAL COMPONENT

    MDR report key: 5945769 · Received September 13, 2016

    Report

    Report Number
    0001822565-2016-03234
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    August 15, 2016
    Report Date
    March 21, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: ZIMMER NEXGEN CR ARTICULAR SURFACE, CATALOG #: 00-5976-030-10, LOT #: 53238300. ZIMMER NEXGEN PRECOAT TIBIAL PLATE, CATALOG #: 00-5980-037-02, LOT #: 60295716. ZIMMER NEXGEN ALL-POLY PATELLA, CATALOG #: 00-5972-065-32, LOT #: 60324119. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE FAILURE RELATED TO PATIENT CONDITION, KNOWN INHERENT RISK OF PROCEDURE, DEVICE NOT RETURNED. COMPLAINT SAMPLE WAS NOT EVALUATED BUT THE REPORTED EVENT WAS CONFIRMED. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. AN OFFICE VISIT WITH THE SURGEON PRIOR TO THE PRIMARY SURGERY NOTED THAT THE PATIENT¿S PAST MEDICAL HISTORY INCLUDED OSTEOPOROSIS. OPERATIVE NOTES FROM THE PRIMARY SURGERY STATE THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT DUE TO OSTEOARTHRITIS. FULL EXTENSION AND FLEXION WITH EXCELLENT STABILITY WERE NOTED WITH THE FINAL IMPLANTS. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. REVIEW OF THE IMPLANTED COMPONENTS IDENTIFIED NO COMPATIBILITY ISSUES. AN ASSESSMENT OF THE RETURNED PATIENT X-RAYS FROM AFTER THE PRIMARY SURGERY SHOW KNEE ARTHROPLASTY COMPONENTS IN EXPECTED POSITION. X-RAYS FROM TWO DAYS BEFORE THE REVISION SURGERY SHOW A TRANSVERSE FRACTURE OF THE DISTAL FEMORAL METAPHYSIS. THE DISTAL FEMORAL FRAGMENT AND FEMORAL ARTHROPLASTY COMPONENT REMAINED ATTACHED. AN EXACT COMPARISON OF THE BONE QUALITY BETWEEN THE POST-OP AND PRE-REVISION X-RAYS COULD NOT BE MADE; HOWEVER, NO DEFINITE CHANGE IN BONE QUALITY OR EVIDENCE OF BONE LOSS WAS NOTED ON THE LATER X-RAY. OPERATIVE NOTES FROM THE REVISION SURGERY STATE THAT THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE OF THE DISTAL FEMUR. DURING REMOVAL OF THE COMPONENTS THE PATIENT¿S BONE WAS NOTED TO BE ¿REALLY FRAIL AND FRAGILE¿. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. PER THE CURRENT NEXGEN CR, PS, CRA, LPS, AND LCCK PACKAGE INSERT AT THE TIME OF THE PRIMARY SURGERY, OSTEOPOROSIS AND INSUFFICIENT BONE STOCK ON THE FEMORAL OR TIBIAL SURFACES ARE LISTED AS CONTRAINDICATIONS FOR USE OF THIS DEVICE. LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES ARE ALSO LISTED AS KNOWN RISKS OF THIS PROCEDURE. IT APPEARS THAT THE FEMORAL FRACTURE WAS CAUSED BY THE PATIENT¿S CONDITION OF OSTEOPOROSIS AND THE PATIENT¿S BONE QUALITY. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY REVISION DUE TO FEMORAL PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599779 NEXGEN CRUCIATE RETAINING PRECOAT FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 7878359

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R