BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -3MM NECK

    MDR report key: 8708358 · Received June 18, 2019

    Report

    Report Number
    0001825034-2019-02613
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    April 5, 2019
    Report Date
    August 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 MEDICAL RECORDS. MEDICAL RECORDS IDENTIFIED THAT THE PATIENT EXPERIENCED PAIN, AND RECEIVED MULTIPLE TREATMENTS, INCLUDING INJECTION AND FASCIOTOMY. PATIENT EVENTUALLY UNDERWENT REVISION DUE TO MECHANICAL COMPLICATION WITH HIP JOINT PROSTHETIC, WITH NEW CUP, LINER, AND HEAD IMPLANTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UDI : (B)(4). 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 03889.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 010000734, LOT NUMBER: 6238040, BRAND NAME: G7 NEUTRAL LINER; CATALOG NUMBER: 010000666, LOT NUMBER: 6183715, BRAND NAME: G7 ACETABULAR CUP; CATALOG NUMBER: 163668, LOT NUMBER: J6207198, BRAND NAME: COCR MODULAR HEAD; CATALOG NUMBER: 192111, LOT NUMBER: 241700, BRAND NAME: ECHO FEMORAL STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02611, 0001825034-2019-02612, 0001825034-2019-02613. 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. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN APPROXIMATELY 10 MONTHS POST IMPLANTATION. 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
    500990 32MM MOD HEAD COCR -3MM NECK PROSTHESIS,HIP JDI ZIMMER BIOMET, INC. N/A J6207198

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization