BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR ARTICULAR SURFACE

    MDR report key: 6110235 · Received November 17, 2016

    Report

    Report Number
    0001822565-2016-04240
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 15, 2014
    Report Date
    August 14, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK003910
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: ZIMMER NEXGEN CR-FLEX GENDER FEMORAL COMPONENT CATALOG #: 00-5750-015-01 LOT #: 62570685, ZIMMER NEXGEN CR PEGGED TIBIAL PLATE CATALOG #: 00-5970-035-02 LOT #: 62577184, ZIMMER NEXGEN ALL-POLY PATELLA CATALOG #: 00-5972-065-32 LOT #: 62423982, HERAEUS PALACOS BONE CEMENT CATALOG #: 00-1113-140-01 LOT #: 77094364.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. COMPLAINT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INFORMATION CONTAINED WITHIN THIS REPORT DOES NOT ALTER PREVIOUS CONCLUSIONS. 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 HAS BEEN REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO LOOSENING.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO LOOSENING. ADDITIONAL INFORMATION RECEIVED INDICATES PATIENT UNDERWENT REVISION OF THE ARTICULAR SURFACE DUE TO INSTABILITY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IN PATIENT'S MEDICAL RECORDS INDICATED THE PATIENT WAS REVISED DUE TO INSTABILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY SECONDARY TO A FALL AND PCL TEAR NINE MONTHS AFTER THE INITIAL PROCEDURE. THE TIBIAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759948 NEXGEN CR ARTICULAR SURFACE KNEE PROSTHESIS JWH ZIMMER, INC. N/A 62054894

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R