BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005180920-2018-00598

    MDR report key: 7734722 · Received July 31, 2018

    Report

    Report Number
    3005180920-2018-00598
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 16, 2018
    Report Date
    July 31, 2018
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 JULY 2018: LOT 110847: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 MAY 2011. EXPIRATION DATE: 2016-03-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF HIP PAIN. THE SURGEON BELIEVES THE STEM IS LOOSE. THE SURGEON PLANS TO PULL THE STEM, HEAD AND LINER AND REPLACE IT WITH ANOTHER COMPANY'S PRODUCT. THE SURGEON REVISED THE PATIENT ON (B)(6) 2018. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. STEM, HEAD AND LINER REVISED. CUP LEFT IN PLACE.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention