BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR PEGGED TIBIAL COMPONENT

    MDR report key: 6000996 · Received October 5, 2016

    Report

    Report Number
    0001822565-2016-03544
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    August 28, 2015
    Report Date
    September 11, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW UP REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INITIAL AND SUPPLEMENTAL MDR WERE INADVERTENTLY SUBMITTED UNDER THE WRONG MFR SITE. A NEW MDR WILL BE SUBMITTED TO RELAY INFORMATION UNDER THE CORRECT MFR REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. CONCOMITANT MEDICAL PRODUCTS - NEXGEN CR-FLEX FEMORAL COMPONENT, PART# 00-5950-017-02 LOT# 62762795; NEXGEN CR PEGGED TIBIAL COMPONENT, PART# 00-5970-045-02 LOT# 62894538; NEXGEN ALL POLY PATELLA, PART# 00-5972-066-38 LOT# 62882850; SIMPLEX BONE CEMENT X2. THE REPORTED EVENT WAS ABLE TO BE CONFIRMED THROUGH OPERATIVE NOTES RECEIVED. NO DEVICES WERE RECEIVED; THEREFORE A VISUAL INSPECTION WAS NOT CONDUCTED. OPERATIVE NOTES FROM THE REVISION SURGERY STATE THAT THE PATIENT WAS REVISED DUE TO A LOOSENED TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AT THE BONE-CEMENT INTERFACE. THE FEMORAL AND PATELLAR COMPONENTS WERE NOT REVISED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 A PATIENT UNDERWENT REVISION OF A RIGHT TOTAL KNEE ARTHROPLASTY DUE TO A LOOSE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650460 NEXGEN CR PEGGED TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 62894538

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R