BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN RHK TIBIAL TRAY

    MDR report key: 6776316 · Received August 9, 2017

    Report

    Report Number
    0001822565-2017-05492
    Event Type
    Injury
    Date Received
    August 9, 2017
    Report Date
    February 7, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    KRO
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MEDICAL PRODUCTS - NG RHK FEM COMP SZ H LT CATALOG # 32855471179, LOT # UNKNOWN, NG RHK ART SURF SZ H 23MM HGT CATALOG #, LOT # UNKNOWN. (B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001822565-2017-05491, 0001822565-2017-05493.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS INFECTION IS GREATER THAN ONE YEAR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL AND INFORMATION. CONCOMITANT MEDICAL PRODUCTS - NG RHK FEM COMP SZ H LT CATALOG # 32855471179, LOT # 95006537, NG RHK ART SURF SZ H 23 MM HGT CATALOG #32855412112, LOT #95006540. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCT WAS RETURNED OR PHOTOS PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE LIMITED 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 WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO INFECTION. NO ADDITIONAL PATIENT CONSEQUENCE WAS REPORTED. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561346 NEXGEN RHK TIBIAL TRAY PROSTHESIS, KNEE KRO ZIMMER, INC. N/A 95006606

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R