BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL

    MDR report key: 7103118 · Received December 10, 2017

    Report

    Report Number
    0001822565-2017-08334
    Event Type
    Malfunction
    Date Received
    December 10, 2017
    Date of Event
    November 14, 2017
    Report Date
    February 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    Z-2297-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PROVISIONAL EXHIBITS SIGNS OF REPEATED USE ( NICKED AND GOUGED ) ALSO HAS FRACTURED ON THE LATERAL SIDE OF POST, ALL PCS RETURNED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE FOR THE PROVISIONAL FRACTURES IS DESIGN DEFICIENCY RELATED TO BENDING/TORSIONAL LOADING ON THE DEVICE. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE TIME OF THE INITIAL MEDWATCH. UPDATED:

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL # 42-5170-003-03 LOT # UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-08333. 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 DURING A KNEE SURGERY THE PROVISIONAL FRACTURED WHEN THE SURGEON WAS PUTTING THE KNEE THROUGH FLEXION, IN A RANGE OF MOTION CHECK. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882044 PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 62716777

    Patients

    Seq Age Sex Outcome Treatment
    1