BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A MODULAR HEAD COMPONENT

    MDR report key: 6935021 · Received October 10, 2017

    Report

    Report Number
    0001825034-2017-08064
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    February 13, 2004
    Report Date
    April 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK003363
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: COLLARLESS BI-METRIC POROUS STEM, CATALOG#: X11-180314, LOT#: 166690, UNIVERSAL ALTERNATE BEARING SHELL, CATALOG#: 15-103684, LOT#: 923020, M2A TAPER LINER, CATALOG#: 15-105004, LOT#: 876740, LOW PROFILE SELF-TAPPING BONE SCREW, CATALOG#: 103537, LOT#: 998530. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. OP NOTES DATED NINE DAYS POST-IMPLANTATION STATES THAT THE PATIENT WAS FOUND TO HAVE A LOW-GRADE FEVER AND A WOUND INFECTION. THERE WERE TWO SMALL SUPERFICIAL SKIN OPENINGS WITH A SMALL AMOUNT OF SEROSANGUINOUS DRAINAGE. THE ENTIRE WOUND WAS PAINFUL, FIRM AND HAD A ERYTHEMATOUS BASE. LAB SHOWED A WHITE COUNT OF 10.9, SED RATE WAS ELEVATED TO 39. X-RAY SHOWED THE HARDWARE IN PLACE. NO LOOSENING AND NO GAS IN THE SOFT TISSUES. THE PATIENT HAD A CENTRAL LINE PLACEMENT 18 DAYS POST-IMPLANTATION TO MAINTAIN PERIPHERAL IVS. THE PATIENT WAS DISCHARGED 24 DAYS AFTER DIAGNOSIS OF INFECTION. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN, UNKNOWN STEM, UNKNOWN. UNKNOWN, UNKNOWN CUP, UNKNOWN. UNKNOWN, UNKNOWN LINER, UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08065, 0001825034-2017-08066, 0001825034-2017-08067.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT DEVELOPED A WOUND INFECTION NINE DAYS POST IMPLANTATION. PATIENT REQUIRED LONG-TERM IV ANTIBIOTIC THERAPY INCLUDING CENTRAL LINE PLACEMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT DEVELOPED AN INFECTION TEN DAYS POST IMPLANTATION. PATIENT REQUIRED LONG-TERM IV ANTIBIOTIC THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716384 M2A MODULAR HEAD COMPONENT PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A 180950

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R