BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR STD NECK

    MDR report key: 8260794 · Received January 18, 2019

    Report

    Report Number
    0001825034-2019-00229
    Event Type
    Injury
    Date Received
    January 18, 2019
    Date of Event
    August 28, 2018
    Report Date
    June 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K974558
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCTS - ECHO POR FMRL LAT, CATALOG #: 192110 LOT #: 940480. 32MM MOD HEAD COCR, CATALOG #: 163669 LOT #: J3759498. G7 PPS LTD ACET SHELL, CATALOG #: 010000663 LOT #: 3654507. G7 NEUTRAL E1 LINER, CATALOG #: 010000849 LOT #: 3471471. REPORT SOURCE: FINLAND. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: STEM: 0001825034-2019-00228, CUP: 0001825034-2019-00230, LINER: 0001825034-2019-00231.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT EXPERIENCED HIP PAIN AND LIMPING APPROXIMATELY 2.5 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54524 32MM MOD HEAD COCR STD NECK PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A J3759498

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other