BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR CUP HAP SIZE 52/58

    MDR report key: 9528320 · Received December 28, 2019

    Report

    Report Number
    3005975929-2019-00444
    Event Type
    Injury
    Date Received
    December 28, 2019
    Report Date
    March 26, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010552310
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 · 1

    IT WAS REPORTED THAT PATIENT SUFFERED A DISTAL FRACTURE OF THE LEFT HIP DUE TO A FALL SHORTLY AFTER IMPLANTATION OF BMHR DEVICES. PLATES AND SCREWS WERE IMPLANTED AND REMOVED 1 YEAR AFTER SURGERY. A SCREW WAS LEFT TRANSFEMORAL BELOW THE HIP PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322994 ACETABULAR CUP HAP SIZE 52/58 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 74122158 03596010552310

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention 74432052 BMHR MODULAR HEAD 52MM| 74435430 BMHR POROUS COATED STEM 4