BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R 1X40 SINGLE

    MDR report key: 6555087 · Received May 9, 2017

    Report

    Report Number
    0001822565-2017-03181
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    May 18, 2015
    Report Date
    June 6, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    PMA / PMN Number
    PK030902
    Removal / Correction Number
    Z-2410-2010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: NEXGEN FEMORAL COMPONENT RIGHT, CATALOG #00576401552 LOT #61019583; NEXGEN MIS TIBIAL COMPONENT, CATALOG #00595003701 LOT #61000889; NEXGEN ARTICULAR SURFACE, CATALOG #00596203212 LOT #61001406; NEXGEN ALL POLY PATELLA, CATALOG #00597206529 LOT #61019003; PALACOS R BONE CEMENT, CATALOG #00111214001 LOT #66774191 (QTY 2). 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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - NEXGEN MIS STEMMED TIBIAL COMPONENT CATALOGUE # 00-5950-037-01, LOT # 61000689. PALACOS BONE CEMENT IS DISTRIBUTED BY (B)(4). REPORTED EVENT WAS ABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED, NOR PHOTOS RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS COULD NOT BE EVALUATED AND VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF DEVICE HISTORY RECORDS FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE OR ANOMALIES. REVIEW OF THE OPERATIVE REPORTS REVEALED NO DEVIATIONS FROM SURGICAL TECHNIQUE IN THE ENTIRE PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILLED ACCORDINGLY. (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 7 YEARS POST-IMPLANTATION DUE TO PAIN. A RIGHT TOTAL KNEE REVISION WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED FROM MEDICAL RECORDS INDICATE THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL AND TIBIAL COMPONENTS. ALSO NOTED THERE WAS SIGNIFICANT AMOUNT OF BONE LOSS ON THE TIBIAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335115 PALACOS R 1X40 SINGLE BONE CEMENT LOD ZIMMER, INC. 66774191

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R