BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-POLY 40MM HIWALL LRN SZ26

    MDR report key: 6940796 · Received October 11, 2017

    Report

    Report Number
    0001825034-2017-08389
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    March 2, 2015
    Report Date
    October 10, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK070399
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PART WAS REVIEWED VISUALLY AND FEATURES RELEVANT TO THE COMPLAINT WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THIS PART WAS FOUND TO BE CONFORMING NOW SO IS BELIEVED TO HAVE BEEN CONFORMING WHEN IT LEFT BIOMET. A DIMENSIONAL ANALYSIS WAS PERFORMED, NO FEATURES WERE FOUND TO BE OUT OF TOLERANCE. THE DHR SHOWS NOTHING OUT OF THE EXPECTED. ALL OPERATIONS WERE IDENTIFIED WITH NO DEVIATIONS OR SCRAP. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION: UNDER WARNING SECTION NOTE 2 STATES, ¿PRIOR TO SEATING THE LINER INTO THE SHELL COMPONENT, ALL SURGICAL DEBRIS (TISSUE FRAGMENTS, ETC.) MUST BE REMOVED FROM THE INTERIOR OF THE SHELL COMPONENT, AS DEBRIS MAY INHIBIT THE LOCKING MECHANISM FROM ENGAGING AND SECURING THE LINER INTO THE SHELL COMPONENT.¿ ALSO WARNING SECTION STATES, "THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE IMPLANTS AND INSTRUMENTS PRIOR TO PERFORMING SURGERY." 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL RIGHT HIP ARTHROPLASTY ON MARCH 2, 2015, THE SURGEON COULD NOT GET THE LINER TO SEAT IN THE CUP. ANOTHER LINER WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721125 E-POLY 40MM HIWALL LRN SZ26 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 923990

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR