BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA FEMORAL PROVISIONAL LEFT SIZE 11

    MDR report key: 6778232 · Received August 9, 2017

    Report

    Report Number
    0001822565-2017-05398
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    May 8, 2017
    Report Date
    April 10, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK123459
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (UDI #): (B)(4). REPORT SOURCE: (B)(6). 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

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PARTS DETERMINED THAT THEY HAD SCRATCHES SUGGESTING REPEATED USE. SEM MICROGRAPHS AND EDS ELEMENTAL ANALYSIS OF THE DEBRIS AND IT WAS FOUND THAT RUST LIKE INDICATION ON THE LASER ETCHED AREAS WHICH SHOWED HIGH CONCENTRATION OF (O, MN AND CL) AND THE DEBRIS INDICATION AREAS WERE MECHANICALLY SMEARED AND WERE FILLED WITH DEBRIS WHICH PREDOMINANTLY SHOWED OXIDES AND SOME AREAS SHOWED CL, C, SI, CA, AND AL. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE IS ATTRIBUTED TO A MAINTENANCE ISSUE. 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 FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INITIAL OPERATING ROOM SETUP, THE NURSE HANDLING THE FEMORAL PROVISIONAL HAD BLACK RESIDUE ON HER GLOVES. THERE WAS NOTICED TO BE BLACK DEBRIS ON THE INSIDE OF THE LEFT AND RIGHT FEMORAL PROVISIONAL. THERE WERE FIVE SETS EXAMINED AND ALL FIVE SETS HAD THE SAME BLACK DEBRIS. AS A RESULT OF THE EVENT, A DELAY IN PROCEDURE OCCURRED APPROXIMATELY 35 MINUTES LONG. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558950 PERSONA FEMORAL PROVISIONAL LEFT SIZE 11 PROSTHESIS, KNEE MBH ZIMMER, INC. N/A 63332585

    Patients

    Seq Age Sex Outcome Treatment
    1 Other