BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT

    MDR report key: 11796934 · Received May 10, 2021

    Report

    Report Number
    3007963827-2021-00102
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    June 10, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE RESULTS OF THE INVESTIGATION ARE AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED DEVICES SHOWS THAT THE DOVE TAIL IS FLARED OUT. THE DEVICES ALSO EXHIBIT SIGNS OF USE (NICKS, GOUGES AND IMPACTION MARKS). REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. ARTICULAR SURFACE IS COMPATIBLE WITH THE TIBIA, HOWEVER ENTIRE CONSTRUCT COMPATIBILITY COULD NOT BE ASSESSED DUE TO INSUFFICIENT INFORMATION. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. MEDICAL RECORDS WERE NOT PROVIDED. ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. COMPLAINT IS CONFIRMED. REFERENCE REPORT: 3007963827-2021-00103-1. 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). CONCOMITANT DEVICES: PSN TIB NP STM 5 DEG SZ D R, CATALOG #: 42-5320-067-02, LOT #: 64761920. REFERENCE REPORT #: 3007963827 - 2021 - 00103. THE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 TOTAL KNEE ARTHROPLASTY THE 10MM ARTICULAR SURFACE WOULD NOT SEAT FLUSH ANTERIOR. INSERT WAS REMOVED AND CHECKED FOR DEBRIS AND TRIED DIFFERENT 10MM ARTICULAR SURFACE WITH THE SAME RESULTS. 11MM ARTICULAR SURFACE WAS IMPLANTED. THE SURGEON HAS PERFORMED AN ESTIMATED 1K+ KNEE SURGERIES. ATTEMPTS HAVE BEEN MADE, BUT NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693104 PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 64478197

    Patients

    Seq Age Sex Outcome Treatment
    1 SEEH10NARRATIVE