BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. SBG STEM

    MDR report key: 7759678 · Received August 7, 2018

    Report

    Report Number
    9613369-2018-00045
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    February 22, 2012
    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 · 1

    RESULTS ON INVESTIGATION: A CHANGE IN STEM FIXATION DESCRIBED AS BONE LOSS WAS REPORTED ALONG WITH RADIOLUCENT LINES AT THE PROXIMAL PART OF THE FEMUR. THE CORRESPONDING X-RAYS WERE NOT PROVIDED. NO INFORMATION ON A TREATMENT OR COMPLICATION AS RESULT OF THE REPORTED FINDINGS WAS PROVIDED. THE PROVIDED CASE REPORT FORMS (CRF) DO NOT CONTAIN FURTHER INFORMATION THAT WOULD ALLOW FURTHER INVESTIGATION OF THE REASONS FOR THE REPORTED ISSUE. NO DEVICE WAS RETURNED AND NO BATCH NUMBER WAS COMMUNICATED. DUE TO INSUFFICIENT INFORMATION, NO INVESTIGATION CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AS PART OF SBG OBSERVATIONAL STUDY (B)(4), SUBJECT (B)(6) EXPERIENCED CHANGE IN STEM FIXATION NOTED ON 5-YEAR FOLLOW-UP RADIOGRAPHICAL EXAMINATION AS "BONE LOSS". 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.

    Description of Event or Problem · 1

    AS PART OF (B)(4) OBSERVATIONAL STUDY, SUBJECT (B)(6) EXPERIENCED CHANGE IN STEM FIXATION NOTED ON 5-YEAR FOLLOW-UP RADIOGRAPHICAL EXAMINATION AS "BONE LOSS". (B)(6) 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)(4) OBSERVATIONAL STUDY DATA UNDERWENT A SYSTEMATIC REVIEW. ANY INDICATION OF PREVIOUSLY UNDOCUMENTED ADVERSE EVENTS HAVE BEEN COLLECTED AND UNDERWENT AN UNIFORMED SPONSORED REVIEW BY (B)(6). EVENTS WERE NEVER CLASSIFIED AS ADVERSE EVENT BY THE REPORTING SURGEON BUT HAVE ONLY RECEIVED SPONSOR'S CLASSIFICATION BY THE (B)(6) ON 16TH JULY 2018. NO FURTHER INFORMATION AVAILABLE NOR ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601702 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 Other