BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ8 STD OFF

    MDR report key: 8577800 · Received May 3, 2019

    Report

    Report Number
    1818910-2019-92416
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    November 2, 2018
    Report Date
    November 2, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 181891
    Product Code
    LPH
    UDI-DI
    10603295059493
    PMA / PMN Number
    K011489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    (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. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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 WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAINFUL METAL ON METAL TOTAL HIP ARTHROPLASTY. FINDINGS INCLUDE A SMALL PSEUDOTUMOR IN THE ANTERIOR ASPECT OF THE ACETABULUM TOWARDS PELVIS. THE STEM WAS CLEANED OF ANY EVIDENCE OF BLACK CORROSIVE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371488 SUMMIT DUOFIX TAP SZ8 STD OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. 181891 DA2K31000 10603295059493

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention