BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA PS ARTICULAR SURFACE

    MDR report key: 7045129 · Received November 20, 2017

    Report

    Report Number
    0002648920-2017-00670
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    May 2, 2017
    Report Date
    January 30, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK113369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. AN ARTICULAR SURFACE WAS RETURNED AND EVALUATED. VISUAL INSPECTION OF THE RETURNED ARTICULAR SURFACE FOUND EXTENSIVE PITTING ON THE CONDYLAR SURFACES. THE DOVETAIL FEATURE WAS FOUND FLARED OUT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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

    (B)(4). CONCOMITANT MEDICAL DEVICES: UNKNOWN KNEE TIBIAL COMPONENT. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. RELATED REPORT FOR THIS EVENT: 0001822565-2017-07978. 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 · 1

    IT WAS REPORTED THE PATIENT WAS REVISED FOR TIBIAL LOOSENING APPROXIMATELY 1.5 YEARS POST IMPLANTATION. IT WAS ALSO NOTED THAT THE ARTICULAR SURFACE IMPLANT LOOKED STRANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826186 PERSONA PS ARTICULAR SURFACE PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 63050010

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R