BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 19964322 · Received August 12, 2024

    Report

    Report Number
    1043534-2010-00113
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    December 14, 2009
    Report Date
    March 20, 2024
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO ADDITIONAL INFORMATION RECEIVED, IT HAS BEEN INDICATED THE COMPLAINT DOES NOT ALLEGE DEFICIENCY IN THE PRODUCT. PLEASE VOID THIS REPORT.

    Additional Manufacturer Narrative · 0

    CONCLUSION: NO FAILURE DETECTED. COMPLAINT HISTORY REVIEWED. VISUAL EXAMINATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECVD 3/24/10: COMPONENTS RETURNED WITH ADDITIONAL ITEM NOT LISTED ON ORIGINAL REPORT. THIS IS THE SAME EVENT AS 1043534-2010-00066, 00067. DEVICE #3: SECTION D(1-7) - BRAND NAME: CONSERVE(R) PLUS CUP, CATALOG #: 3802-1160, LOT #: 09349873, PRODUCT CODE: KWA. SECTION G(5) - 510K #: K021349.

    Description of Event or Problem · 0

    ORIG. SURG. (B)(6) 2006. MALE, DOB (B)(6) 1954, LEFT HIP. ALLEGEDLY FRACTURE OCCURRED THROUGH THE BASE OF THE NECK OF THE IMPLANT.

    Description of Event or Problem · 0

    ORIG. SURG. ON (B)(6) 2006. MALE, DOB 1954, LEFT HIP. ALLEGEDLY FRACTURE OCCURRED THROUGH THE BASE OF THE NECK OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2275502 CONSERVE(R) PLUS CUP KWA LZO WRIGHT MEDICAL TECHNOLOGY, INC. NA 09349873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention