BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO B-MTRC MP RP SO 8

    MDR report key: 8648403 · Received May 28, 2019

    Report

    Report Number
    0001825034-2019-02338
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 4, 2019
    Report Date
    August 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K143009
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE STEM WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE STEM WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET G7 SHELL CAT#010000662 LOT#6395394, BIOMET TAPER SLEEVE CAT#650-1064 LOT#2955104, BIOMET HEAD CAT#650-1057 LOT#2955098, ZIMMER BONE SCREW CAT#00625006530 LOT#64228001, BIOMET LINER CAT#010000817 LOT#6354149. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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: 0001825034 - 2019 - 02337.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT UNDERWENT AN I&D PROCEDURE APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO INFECTION. IT WAS NOTED THE CERAMIC HEAD, LINER, SCREW AND TAPER WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441210 ECHO B-MTRC MP RP SO 8 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 668350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R