BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR CUP HAP SIZE 48/54

    MDR report key: 7935569 · Received October 4, 2018

    Report

    Report Number
    3005975929-2018-00365
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    April 27, 2018
    Report Date
    August 20, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010552297
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SMITH & NEPHEW IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, 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, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. - ATTACHMENT: [211561 SUMMARY.PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO ALVAL AND PSEUDOTUMOUR. BILATERAL IMPLANTATION AND REVISION PROCEDURES. THIS IS FOR RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776304 ACETABULAR CUP HAP SIZE 48/54 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 09DW23015 03596010552297

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 71356107/ANTHOLOGY HO POROUS SZ 7/10HM11532| 74222148/BHR MODULAR HEAD 48MM/09DW23058| 74222200/MODULAR SLEEVE {} PLUS 0MM 12/14/10BW2577