BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. SBG STEM

    MDR report key: 7759677 · Received August 7, 2018

    Report

    Report Number
    9613369-2018-00046
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    April 22, 2008
    Report Date
    November 13, 2018
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL ASSESSMENT WAS NOT PROPERLY PERFORMED AND MDR WAS FILED BY ERROR. THE EVENT WAS NOT CONSIDERED SERIOUS AS NO INDICATION OF TREATMENT OR SIGNIFICANT COMPLICATIONS DUE TO THIS EVENT WERE NOTED. EVENT DID NOT LED TO THE DEATH OR A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE A PERMANENT IMPAIRMENT TO A BODY PART OR FUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    AS PART OF (B)(6) STUDY (B)(6) EXPERIENCED "THIN SCALE DEMOLITION TROCHANTER MAJOR - NEW OBSERVATION WHEN COMPARED TO 3 MONTHS FOLLOW-UP" AS NOTED IN COMMENT SECTION ON 1-YEAR FOLLOW-UP RADIOGRAPHICAL EXAMINATION. AEMB CLASSIFIED THIS EVENT AS ADVERSE DEVICE EFFECT (ADE). THE EVENT WAS NOT CONSIDERED SERIOUS AS NO INDICATION OF TREATMENT OR SIGNIFICANT COMPLICATIONS DUE TO THIS EVENT WERE NOTED. PLEASE BE AWARE THAT AS PART OF STUDY REPORTING PHASE ALL (B)(6) STUDY DATA UNDERWENT A SYSTEMATIC REVIEW. ANY INDICATION OF PREVIOUSLY UNDOCUMENTED ADVERSE EVENTS HAVE BEEN COLLECTED AND UNDERWENT AN UNIFORMED SPONSORED REVIEW BY AEMB. EVENTS WERE NEVER CLASSIFIED AS ADVERSE EVENT BY THE REPORTING SURGEON BUT HAVE ONLY RECEIVED SPONSOR'S CLASSIFICATION BY THE AEMB ON 16TH JULY 2018. NO FURTHER INFORMATION AVAILABLE NOR ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601473 UNKN. SBG STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other