BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMI HEAD 50MM

    MDR report key: 8108011 · Received November 27, 2018

    Report

    Report Number
    3005975929-2018-00496
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    March 2, 2017
    Report Date
    February 13, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    JDH
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LEFT HIP 2 STAGE REVISION SURGERY WAS PERFORMED DUE TO INFECTION AND ELEVATED TEST RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY FROM THE LEFT HIP WAS PERFORMED DUE TO UNKNOWN REASONS. ANOTHER REVISION SURGERY FROM UNKNOWN DEVICES WAS PERFORMED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948875 HEMI HEAD 50MM PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW ORTHOPAEDICS LTD 10729

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ACETABULAR LINER, # 71341162, LOT # 09AW21141| ACETABULAR SHELL, # 71335562, LOT # 08HM16092| FEMORAL STEM, # 71357011, LOT # 08KM17401A| MODULAR SLEEVE, # 74222200, LOT # 09BW21807| UNKNOWN DEVICE/UNKNOWN LOT