BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -6

    MDR report key: 7754180 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-05817
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    June 26, 2012
    Report Date
    October 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE NOTES PROVIDED. REVIEW OF OPERATIVE CONFIRMS THAT THE PATIENT UNDERWENT INCISION, DRAINAGE, DEBRIDEMENT, AND ONE STAGE REVISION OF RIGHT HIP ARTHROPLASTY REVISION DUE TO INFECTION. DURING THE PROCEDURE, ALL COMPONENTS WERE REMOVED AND NEW IMPLANTS WERE IMPLANTED. IT WAS NOTED THAT THE BONE WAS VERY HARD AND WHILE ATTEMPTING TO SEAT THE SCREW, THE SCREW BROKE. IT WAS DECIDED TO LEAVE THE BROKEN PORTION IN SITU, AS THE CUP WAS IN GOOD POSITION AND EXCELLENT POSITION FIXATION WITH THE TWO 20 SCREWS HAD BEEN OBTAINED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: N/A. ITEM # 51-107120, STEM, LOT # 2483494. ITEM # 650-1057, HEAD, LOT # 423650. ITEM # 11-104062, SHELL, LOT # 160680. ITEM # EP-105996, LINER, LOT # 690770. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 05813. 0001825034 - 2018 - 05814. 0001825034 - 2018 - 05815. 0001825034 - 2018 - 05816.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS POST IMPLANTATION, THE PATIENT UNDERWENT AN INCISION, DRAINAGE, DEBRIDEMENT, AND REMOVAL OF THE PROSTHESIS WITH A SINGLE STAGE EXCHANGE DUE TO INFECTION. THE PATIENT HAD BEEN EXPERIENCING DRAINAGE FROM THE WOUND OVER SEVERAL WEEKS AND ATTEMPTS TO TREAT WITH ORAL ANTIBIOTICS CONSERVATIVELY WERE UNSUCCESSFUL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593968 CER OPTION TYPE 1 TPR SLEVE -6 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 408520

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R