BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT CEMENTED STEM SZ6 HI

    MDR report key: 8682610 · Received June 10, 2019

    Report

    Report Number
    1818910-2019-95569
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 16, 2019
    Report Date
    May 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    UDI-DI
    10603295060253
    PMA / PMN Number
    K013352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DVTS BILATERALLY: VASCULAR - DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2019; DOR: (B)(6) 2019 ,(PELVIC FRACTURE: CUP, LINER, AND HEAD REVISED); DOE: (B)(6) 2019, (RIGHT HIP). DEPUY HIP COMPONENTS PRESENT AT THE TIME OF THE AE: CATALOG ID: 101185000, LOT: 348034, DESCRIPTION: PROTRUSIO CAGE 48MM X 45MM RT; CATALOG ID: 122132048, LOT: J19U80, DESCRIPTION: PINNACLE ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 32MM ID 48MM OD; CATALOG ID: 136521000, LOT: D18122792, DESCRIPTION: ARTICUL/EZE HEAD COCR 32MM +1; CATALOG ID: 545032500, LOT: 8719593, DESCRIPTION: DEPUY CMW 2 GENTAMICIN BONE CEMENT ; CATALOG ID: 545032500, LOT: 8939042, DESCRIPTION: DEPUY CMW 2 GENTAMICIN BONE CEMENT ; CATALOG ID: 3322020, LOT: 8885300, DESCRIPTION: SMART SET BONE CEMENT 20G; CATALOG ID: 101140020, LOT: J30C19, DESCRIPTION: SELF TAPPING SCREW 20MM; CATALOG ID: 101140020, LOT: J30C19, DESCRIPTION: SELF TAPPING SCREW 20MM; CATALOG ID: 101140015, LOT: 371070, DESCRIPTION: ROOF PILE SCREW 15MM; CATALOG ID: 101140025, LOT: HD7680, DESCRIPTION: ROOF PILE SCREW 25MM; CATALOG ID: 101140030, LOT: J30C36, DESCRIPTION: ROOF PILE SCREW 30MM; CATALOG ID: 101140025, LOT: J09T28, DESCRIPTION: ROOF PILE SCREW 25MM; CATALOG ID: 101140030, LOT: J30C37, DESCRIPTION: ROOF PILE SCREW 30MM; CATALOG ID: 101140015, LOT: H59257, DESCRIPTION: ROOF PILE SCREW 15MM; CATALOG ID: 137622000, LOT: J1524P, DESCRIPTION: CEMENTRALIZER DISTAL 13.0MM; CATALOG ID: 157013120, LOT: D19021860, DESCRIPTION: SUMMIT STEM CEMENTED HIGH OFFSET SZ 6 12/14 TAPER; CATALOG ID: 3312040, LOT: 8708235, DESCRIPTION: SMART SET CMW 1 40G; CATALOG ID: 3312040, LOT: 8708235, DESCRIPTION: SMART SET CMW 1 40G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475144 SUMMIT CEMENTED STEM SZ6 HI SUMMIT HIP STEM : HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US D19021860 10603295060253

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention