BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 10 MM HEIGHT

    MDR report key: 11709014 · Received April 22, 2021

    Report

    Report Number
    3007963827-2021-00093
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 12, 2021
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024236448
    PMA / PMN Number
    K172524
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION OF THE RETURNED DEVICE EXHIBITS DAMAGE AT THE DISTAL SURFACE AND THE DOVE TAIL/LOCKING FEATURES IS FLARED OUT. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 42532006701, TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE D, 64851598. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER 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 AFTER THE SURGEON INSERTED ARTICULAR SURFACE IMPLANT, THEY NOTICED THERE WAS A GAP AT THE ANTERIOR PART BETWEEN THE ARTICULAR SURFACE AND THE TIBIA TRAY. THE SURGEON WAS NOT SATISFIED WITH THE PLACEMENT OF THE INSERT AND HE INSISTED TO REINSERT THE SAME ARTICULAR SURFACE. UNFORTUNATELY, THE ARTICULAR SURFACE STILL COULD NOT SIT PROPERLY INTO THE TIBIAL TRAY. THEREFORE, THE SURGEON REQUESTED TO OPEN THE NEW ARTICULAR SURFACE. WITH THE NEW ARTICULAR SURFACE IT CAN SIT PROPERLY ONTO THE TIBIAL TRAY. THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO SURGICAL DELAY AND THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605472 ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 10 MM HEIGHT PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64647734 00889024236448

    Patients

    Seq Age Sex Outcome Treatment
    1