BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 6521739 · Received April 26, 2017

    Report

    Report Number
    0001822565-2017-02399
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    October 23, 2015
    Report Date
    August 22, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - SHELL POROUS WITH CLUSTER HOLES 54 MM/ PN 00620205422/ LN 60504591, LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS/ PN 00630505036/ LN 60494762, UNKNOWN STEM. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-02397, 0001822565-2017-02398.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 0001822565-2017-02397-1, 0001822565-2017-02398-1, 0001822565-2017-05606. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED FOR CORRECTION: EXPLANT DATE SHOULD BE N/A. 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 PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO FAILED TOTAL HIP ARTHROPLASTY AND ADVERSE TISSUE REACTION. DURING THE REVISION, THAT THE HIP AREA CONTAINED A SIGNIFICANT AMOUNT OF YELLOW FLUID WHICH WAS CONSISTENT WITH METALLOSIS AND TISSUE REACTION. THE ILIOPSOAS TENDON WAS COMPLETELY DESTROYED. METALLOSIS INSIDE THE FEMORAL HEAD WAS NOTED. THERE WAS OSTEOLYSIS OF THE ACETABULUM AND THE POLY LINER WAS IDENTIFIED AS HAVING A YELLOW DISCOLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303907 UNKNOWN HEAD PROSTHESIS, HIP JDI ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R