BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. SBG STEM

    MDR report key: 7759683 · Received August 7, 2018

    Report

    Report Number
    9613369-2018-00047
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    October 10, 2007
    Report Date
    September 9, 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

    RESULTS OF INVESTIGATION: AN INTRA-OPERATIVE TROCHANTERIC FRACTURE WAS REPORTED. NO DEVICE WAS RETURNED FOR EVALUATION. NO BATCH NUMBER WAS COMMUNICATED. BASED ON THE AVAILABLE INFORMATION NO INVESTIGATION CAN BE PERFORMED. NO FURTHER ACTIONS HAVE BEEN INITIATED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    AS PART OF (B)(6) STUDY (B)(6) EXPERIENCED INTRAOPERATIVE COMPLICATION "TROCHANTERIC FRACTURE". AEMB CLASSIFIED THIS EVENT AS SERIOUS ADVERSE DEVICE EFFECT (SADE) WITH SPECIAL EMPHASIS ON SURGICAL TECHNIQUE. AT 3-MONTH POST-OP PATIENT WAS NOTED TO USE 2 STICKS FOR WALKING DUE TO INITIAL PARTIAL WEIGHT-BEARING OF 15 KG FOR 8 WEEKS. NO OTHER INDICATION OF TREATMENT OR COMPLICATIONS DUE TO THIS EVENT. 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
    601703 UNKN. SBG STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other