BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ4 STD OFF

    MDR report key: 6151068 · Received December 7, 2016

    Report

    Report Number
    1818910-2016-32965
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    September 3, 2008
    Report Date
    March 10, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) 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. DEVICE HISTORY LOT ==> NULL DEVICE HISTORY BATCH ==> NULL DEVICE HISTORY REVIEW ==> NULL 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

    PATIENT REVISED TO ADDRESS MAL-POSITIONED CUP AND SQUEAKING. UPDATE REC'D 11/16/2016 UPDATE REC¿D XX/XX/XXXX - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALSO ALLEGES THE PATIENT SUFFERS FROM METALLOSIS, PAIN, DISCOMFORT DIFFICULTY AMBULATING AND ELEVATED IONS. ADDING THE HEAD, LINER AND STEM TO THE COMPLAINT.

    Description of Event or Problem · 1

    UPDATE: 03/10/2017 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE PFS AND MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED TO ADDRESS PAIN, DISCOMFORT, AND RECURRENT DISLOCATING RIGHT HIP. THE FEMORAL HEAD HAD SCRATCHING FROM IMPINGEMENT AND METAL DEBRIS WAS REPORTED. METAL ION LEVELS PROVIDED WERE AT NON-REPORTABLE LEVELS. THE COMPLAINT WAS UPDATED: 03/31/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802347 SUMMIT DUOFIX TAP SZ4 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. 1818910 V4VBM1008

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention