BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROVISIONAL ARTICULAR SURFACE

    MDR report key: 9756746 · Received February 26, 2020

    Report

    Report Number
    0001822565-2020-00604
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    January 31, 2020
    Report Date
    March 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED SIGNS OF REPEATED USE (NICKED OR GOUGED) ALSO IS FRACTURED. SEM ANALYSIS NOT REQUIRED SINCE THE DEVICE HAS A POTENTIAL FIELD AGE OF 9.5 YEARS AND SHOWS SIGNS OF REPEATED USE. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE LOT WAS MANUFACTURED ON 15 JULY 2010 AND HAS THEREFORE BEEN IN THE FIELD FOR APPROXIMATELY 10 YEARS. IT IS UNKNOWN FOR HOW MANY TIMES THE DEVICE IS BEING USED. BASED ON THE INFORMATION AVAILABLE, ROOT CAUSE CAN BE DETERMINED AS NORMAL WEAR FROM USE DURING THE INSTRUMENT¿S FIELD LIFE. 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). PMA/510K: ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K113369. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FRACTURED DURING PROCEDURE WHILE PERFORMING RANGE OF MOTION TEST. THERE WAS NO IMPACT TO PATIENT. ALL PIECES WERE REMOVE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221635 NEXGEN PROVISIONAL ARTICULAR SURFACE PROSTHESIS, KNEE HWT ZIMMER BIOMET, INC. N/A 61557442

    Patients

    Seq Age Sex Outcome Treatment
    1