BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA MEDIAL CONGRUENT (MC) ARTICULAR SURFACE LEFT 11MM

    MDR report key: 11737066 · Received April 28, 2021

    Report

    Report Number
    3007963827-2021-00096
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 7, 2021
    Report Date
    August 24, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOS PROVIDED. DEVICE WAS NOT RETURNED. VISUAL EVALUATION OF THE PICTURES SHOWS A HAIR-LIKE DEBRIS ON THE OPENED PRODUCT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE PRODUCT HAS BEEN OPENED AND THE SOURCE OF THE HAIR-LIKE DEBRIS CANNOT BE CONFIRMED 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: TYPE OF INVESTIGATION - 4114 - DEVICE NOT RETURNED CODE IS N/A WHICH WAS REPORTED ON INITIAL REPORT. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS A RED HAIR-LIKE DEBRIS ON THE OPENED PRODUCT. ADDITIONAL INFORMATION DOES NOT AFFECT THE ROOT CAUSE. 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.

    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: (B)(6). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING KNEE ARTHROPLASTY WHEN THE ARTICULAR SURFACE IMPLANT WAS OPENED, A SMALL RED HAIR-LIKE SUBSTANCE WAS IDENTIFIED ON THE TOP OF THE DEVICE. A NEW ARTICULAR SURFACE IMPLANT WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638432 PERSONA MEDIAL CONGRUENT (MC) ARTICULAR SURFACE LEFT 11MM PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64473248

    Patients

    Seq Age Sex Outcome Treatment
    1