BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS

    MDR report key: 1894097 · Received November 9, 2010

    Report

    Report Number
    9613369-2010-00064
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    December 27, 2010
    Report Date
    November 9, 2010
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    HSD
    Removal / Correction Number
    R1001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECT PRODUCT INFORMATION SUBMITTED. EVALUATION PREVIOUSLY SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND SEX ADDED. DATES OF THE INITIAL SURGERY AND THE REVISION ADDED.

    Additional Manufacturer Narrative · 1

    THE INCLINATION SET WAS MECHANICALLY LOCKED VIA THE TAPER WITH THE HUMERAL HEAD. THE GRIT-BLASTED SURFACE OF THE INCLINATION SET SADDLE JOINT SHOWED SIGNS OF BURNISHING, WHERE THE TWO MATING SURFACES SLID PAST ONE ANOTHER. THIS HAS THE POTENTIAL TO CAUSE SHOULDER INSTABILITY, AND THE SADDLE JOINT WAS MOST LIKELY CONTINUALLY LOADED UNTIL AN OVERLOAD FRACTURE OCCURRED. THE INCLINATION SET SCREW ALSO FRACTURED IN THE SHAFT. BURNISHING AND FATIGUE STRIATIONS WERE OBSERVED ON THE FRACTURE SURFACE OF THE INCLINATION SET SCREW. FATIGUE STRIATIONS ARE PARALLEL MICROSCOPIC FEATURES WHICH INDICATE METAL CRACKING, WHEREAS BURNISHING ON A FRACTURE SURFACE ARE SMOOTH MICROSCOPIC FEATURES THAT ARE INDICATIVE OF TWO SURFACES CONTACTING ONE ANOTHER AFTER CRACK INITIATION. BOTH FATIGUE STRIATIONS AND BURNISHING CAN BE CAUSED BY REPETITIVE CYCLICAL LOADING. IF THE SUSTAINED LOADING EXCEEDS THE MATERIAL ENDURANCE LIMIT, A CRACK BEGINS TO FORM AND CONTINUES TO PROPAGATE UNTIL THE CROSS-SECTIONAL AREA CAN NO LONGER BEAR THE LOAD. AT THIS POINT, FRACTURE OCCURS. NO MATERIAL DEFECTS OF THE INCLINATION SET SCREW WERE FOUND. THE RETURNED BODY AND STEM BOTH SHOWED SIGNS OF MACROSCOPIC PLASTIC DEFORMATION AND SCRATCHING. DEFORMATION ON THE BODY OF THE POKER CHIP MECHANISM THAT ACCEPTS THE INCLINATION SET WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    PRODUCT INFORMATION ADDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCLINATION SET HAS FRACTURED AND A REVISION SURGERY WILL BE REQUIRED TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS PLUS PROMOS INCLINATION SET 24 MM HSD SMITH & NEPHEW, INC A0702488

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention (B)(4)