BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT

    MDR report key: 11723234 · Received April 26, 2021

    Report

    Report Number
    3007963827-2021-00094
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 28, 2021
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024242982
    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 EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF USE: NICKS, GOUGES AND IMPACT MARKS. THE LOCKING/DOVETAIL FEATURE 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: 42532006702, PSN TIB NP STM 5 DEG SZ D R, 64884656. 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 AFTER THE SURGEON INSERTED THE ARTICULAR SURFACE IMPLANT, THE SURGEON NOTICED THERE WAS A GAP AT THE ANTERIOR PART BETWEEN THE ARTICULAR SURFACE AND THE TIBIA TRAY. THE SURGEON REMOVED AND REINSERTED THE SAME ARTICULAR SURFACE. UNFORTUNATELY, THE ARTICULAR SURFACE STILL COULD NOT SIT PROPERLY INTO TIBIA TRAY. THERE WAS A GAP BETWEEN ARTICULAR SURFACE AND TIBIA TRAY AT THE ANTERIOR BUT POSTERIORLY SAT NICELY. THEREFORE, THE SURGEON REQUESTED TO OPEN THE NEW ARTICULAR SURFACE. WITH THE NEW ARTICULAR SURFACE, IT CAN SIT PROPERLY ONTO THE TIBIA TRAY. THE SURGEON SUSPECT THIS BATCH OF IMPLANTS HAS A MANUFACTURER PRODUCT DEFECT. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623296 ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64556901 00889024242982

    Patients

    Seq Age Sex Outcome Treatment
    1