BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK

    MDR report key: 14348656 · Received May 10, 2022

    Report

    Report Number
    3010536692-2022-00163
    Event Type
    Injury
    Date Received
    May 10, 2022
    Report Date
    August 30, 2022
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 0

    DUE TO ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT, THIS MANUFACTURER REPORT (B)(4) IT'S CONSIDERED NO LONGER REPORTABLE SINCE THERE IS NO ALLEGED DEFICIENCY AND NO DIRECT COMPLAINT STATED AGAINST THE DEVICE OF THIS REPORT(PHA04662 RIM-LOCK). PLEASE VOID THIS REPORT.

    Description of Event or Problem · 0

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS COMPONENTS NOT REVISED: PRODUCT:PROFEMUR® L HIP STEM SIZE 5 HA COATED, PRODUCT ID: PHA05510, LOT#:1674917, QTY:1. PRODUCT:PROFEMUR® NECK A/R 8DGLONG COBALT CHROME, PRODUCT ID: PHAC1234, LOT#:1830376, QTY:1. REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791171 RIM-LOCK HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PHA04662 1887232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention