BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT

    MDR report key: 11938229 · Received June 4, 2021

    Report

    Report Number
    3007963827-2021-00125
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    PMA / PMN Number
    K150090
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE TIBIAL INSERT WOULD NOT SEAT INTO THE TIBIAL TRAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839271 ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64990815

    Patients

    Seq Age Sex Outcome Treatment
    1