BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKN. SBG STEM

    MDR report key: 7759674 · Received August 7, 2018

    Report

    Report Number
    9613369-2018-00044
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    August 15, 2006
    Report Date
    September 13, 2018
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: A CHANGE IN THE POSITION OF A SBG STEM WAS REPORTED. NO DEVICE WAS RETURNED FOR EVALUATION. NO BATCH NUMBER WAS COMMUNICATED. A 3 DEGREE VARUS TILTING WAS NOTED ON 1-YEAR FOLLOW-UP RADIOGRAPHIC EXAMINATION, THE CORRESPONDING X-RAYS WERE NOT AVAILABLE. NO INFORMATION ON A TREATMENT OR COMPLICATION AS RESULT OF THE REPORTED ISSUE WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION NO INVESTIGATION CAN BE PERFORMED. NO FURTHER ACTIONS HAVE BEEN INITIATED. IF ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    AS PART OF (B)(6) STUDY (B)(6) EXPERIENCED CHANGE IN STEM POSITION NOTED ON 1-YEAR FOLLOW-UP RADIOGRAPHICAL EXAMINATION AS "VARUS TILTING 3°". 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 SBG OBSERVATIONAL 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
    601156 UNKN. SBG STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR