BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION, TM STANDARD PRIMARY PATELLA

    MDR report key: 7564119 · Received June 3, 2018

    Report

    Report Number
    3005751028-2018-00035
    Event Type
    Injury
    Date Received
    June 3, 2018
    Date of Event
    November 28, 2017
    Report Date
    April 27, 2020
    Manufacturer
    ZIMMER TMT
    Product Code
    MBH
    PMA / PMN Number
    PK031462
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT UPDATED. NOT REPORTABLE: UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED UNDER 0001822565-2018-02927.

    Additional Manufacturer Narrative · 0

    SURGERY IS FOR REVISION OF A PRIMARY TKA WHICH OCCURRED APPROXIMATELY 1 YEAR 3 MONTHS AFTER THE PRIMARY SURGERY. THE FEMORAL COMPONENT WAS FOUND TO BE COMPATIBLE WITH THE TM PATELLA THAT WAS IMPLANTED DURING THE PRIMARY SURGERY. THE REVISION COMPONENTS THAT WERE DOCUMENTED IN THE OPERATIVE REPORT DID NOT INCLUDE A PATELLAR IMPLANT NOR DID THE OPERATIVE REPORT NARRATIVE INDICATE THAT THE TM PATELLA WAS EXPLANTED. THEREFORE IT APPEARS THAT THE TM PATELLA REMAINS IMPLANTED. AS A RESULT, THIS ENGINEERING INVESTIGATION FINDS NO EVIDENCE THAT THE TM STANDARD PRIMARY PATELLA, SIZE 38, P/N 04-211-38101 (00-5878-065-38) WITH LOT NO. 63356393 WAS REVISED OR FAILED TO PERFORM AS INTENDED. THIS INVESTIGATION BY PRODUCT DEVELOPMENT/POST-MARKET ENGINEERING IS CONSIDERED CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION MAY BE RE-OPENED.

    Description of Event or Problem · 0

    NOT REPORTABLE: UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED UNDER 0001822565-2018-02927.

    Description of Event or Problem · 0

    REVISION DUE TO INSTABILITY AND PAIN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS. DEVICE LOCATION UNKNOWN.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT INITIAL LEFT HIP PROCEDURE ON (B)(6) 2016. FURTHER THE LEGAL COUNSEL REPORTS THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017 DUE TO PAIN AND INSTABILITY. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. TM PATELLA IS THE ONLY TMT DESIGN CONTROLLED PART. AS PER AVAILABLE INFORMATION, THERE IS NO EVIDENCE OF THE REVISION OF TM PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406419 NEXGEN COMPLETE KNEE SOLUTION, TM STANDARD PRIMARY PATELLA MBH ZIMMER TMT N/A 63356393

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention