BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X20MM

    MDR report key: 7971057 · Received October 16, 2018

    Report

    Report Number
    0001825034-2018-09734
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    December 20, 2013
    Report Date
    October 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. MULTIPLE MDR'S WERE REPORTED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED EVENTS: 0001825034 - 2018 - 04806 ; 0001825034 - 2018 - 04807 ; 0001825034 - 2018 - 04808 ; 0001825034 - 2018 - 04809; 0001825034-2018-04810; 0001825034 - 2018 - 09741 . MEDICAL DEVICES: 51-107110 TAPERLOC STEM LOT 2921960; 11-363660 FEMORAL HEAD LOT 923630; 13-104154 RLC SHELL LOT 743650; EP-105994 LINER LOT UNKNOWN; ITEM# 103531 TI LOW PROFILE SCREW 6.5X20MM LOT# 283810; ITEM# 103533 TI LOW PROFILE SCREW 6.5X30MM LOT# 998640. REPORTED INFECTION AND FEMORAL STEM LOOSENING EVENT WERE CONFIRMED DUE TO MEDICAL RECORDS RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES WERE IDENTIFIED. 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 · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS SEVERE PAIN, GROSS INFECTION, AND LACK OF FEMORAL STEM IN-GROWTH. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810984 TI LOW PROFILE SCREW 6.5X20MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 283810

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R