BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA REVISION ARTICULAR SURFACE FIXED BEARING CCK LEFT 14 MM HEIGHT

    MDR report key: 19459599 · Received June 4, 2024

    Report

    Report Number
    0001822565-2024-01861
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 1, 2024
    Report Date
    September 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024554603
    PMA / PMN Number
    K191625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCT: ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK) LEFT 18 MM HEIGHT: CATALOG#42512801018, LOT#64573043; TIBIA FIXED CEMENTED LEFT SIZE G: CATALOG#42542007901, LOT#65509935. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: REVISION OP NOTES: CCK POLY WOULD NOT ENGAGE THE TIBIAL PLATE, PS ARTICULAR SURFACE PLACED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINT IS CONFIRMED WITH THE PROVIDED MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RIGHT REVISION TOTAL KNEE ARTHROPLASTY, THE CONSTRAINED CONDYLAR ARTICULAR SURFACE WOULD NOT ENGAGE WITH THE TIBIAL TRAY AND WAS UNABLE TO BE IMPLANTED. A POSTERIOR STABILIZING BEARING WAS ABLE TO SEAT WITHOUT COMPLICATION AND THE PROCEDURE WAS COMPLETED. NO PATIENT IMPACT OR ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173706 PERSONA REVISION ARTICULAR SURFACE FIXED BEARING CCK LEFT 14 MM HEIGHT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 64338838 00889024554603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H11 NARRATIVE.