BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BICON-PLUS SHELL

    MDR report key: 15407324 · Received September 12, 2022

    Report

    Report Number
    9613369-2022-00501
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    November 16, 2009
    Report Date
    October 7, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). QU, H., ZHANG, W., SUN, S., LIU, Q., LI, B., & SUN, X. (2009). BICON-THREADED CUP FOR TREATING HIP RHEUMATOID ARTHRITIS IN 24 CASES. CHINESE JOURNAL OF TISSUE ENGINEERING RESEARCH, 10231-10235.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON THE LITERATURE REVIEW "BICON-THREADED CUP FOR TREATING HIP RHEUMATOID ARTHRITIS IN 24 CASES", A TOTAL OF 24 PATIENTS UNDERWENT AN INDEX SURGERY WHERE A BICON PLUS SHELL AND A SL-PLUS STEM WERE IMPLANTED AS PART OF A TOTAL HIP REPLACEMENT PROCEDURE. FROM THIS COHORT, A TOTAL OF TWO (2) PATIENTS EXPERIENCED GASTROCNEMIUS STATIC ARTERIAL THROMBOSIS. PATIENTS RECOVERED AFTER NON-SURGICAL TREATMENT, BUT IT IS UNKNOWN WHAT SPECIFIC TREATMENT WAS PERFORMED. FURTHER INFORMATION IS NOT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666416 BICON-PLUS SHELL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED LWJ SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNKN. SL-PLUS STEM