BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDAPT SLVLS MONO STEM 190MM SZ 20 SO

    MDR report key: 9082965 · Received September 18, 2019

    Report

    Report Number
    1020279-2019-03424
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 19, 2019
    Report Date
    June 16, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LZO
    PMA / PMN Number
    K151902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 SURGEON TEMPLATED FOR A REDAPT HIGH OFFSET STEM BEFORE THE PROCEDURE, DURING THR TRIALED WITH A HO STEM AND REQUESTED THAT STEM TO BE OPENED. THE REP GRABBED THE STANDARD STEM. SHOWED THE SURGEON AND NURSE WHILST READING OUT THE LABEL, NO ONE NOTICED THAT IT WAS A STANDARD RATHER THAN HO BEING CHECKED. THE NURSE OPENED THE STEM AND IT WAS IMPLANTED. THE HEAD WAS TRIALED AGAIN AND THE LEG LENGTH AND OFFSET WERE CHECKED USING THE SURGEONS DEVICE. THE SURGEON PUT IN THE DEFINITIVE HEAD AND SEEMED HAPPY WITH THE END RESULT. IT WAS AFTER THE SURGEON HAD UNSCRUBBED THAT HE REALISED THAT THE INCORRECT STEM WAS INSERTED AND CALLED THE REP. NO MORE INFORMATION AVAILABLE. S&N BACKUP DEVICE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878374 REDAPT SLVLS MONO STEM 190MM SZ 20 SO PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT LZO SMITH & NEPHEW, INC. 17CTM0113B

    Patients

    Seq Age Sex Outcome Treatment
    1