BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD -6MM

    MDR report key: 7771697 · Received August 10, 2018

    Report

    Report Number
    0001825034-2018-08034
    Event Type
    Injury
    Date Received
    August 10, 2018
    Date of Event
    September 10, 2013
    Report Date
    August 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 08033; 0001825034 - 2018 - 08035; 0001825034 - 2018 - 08036. CONCOMITANT MEDICAL PRODUCTS: 15-103205, TAPERLOC MICRO LAT FMRL 11MM, LOT 982240;  11-104056, M/H SLD/APX HLE RNGLC SHL 56MM, LOT 389220; EP-105914, EPOLY 36MM RINGLC LNR HW SZ24, LOT 711310. REPORTED EVENT WAS CONFIRMED DUE TO REVIEW OF PROVIDED MEDICAL RECORDS AND/OR PATIENT X-RAYS. DHR WAS REVIEWED AND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES WERE IDENTIFIED. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A TROCHANTERIC BURSECTOMY AND ILIOTIBIAL RELEASE TO ADDRESS BURSITIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612718 36MM COCR MOD HD -6MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 744020

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R