BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ5 STD OFF

    MDR report key: 4242102 · Received November 10, 2014

    Report

    Report Number
    1818910-2014-31496
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    October 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK011489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST FEMORAL HEAD AND INSERT. PER PROCEDURE, THIS DEVICE(S) IS EXEMPT FROM DEVICE HISTORY RECORD REVIEW. HOWEVER, A COMPLAINT DATABASE SEARCH FOUND ADDITIONAL REPORTS AGAINST THE 2590332 LOT CODE. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 2590332 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATION. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. FROM THE INFORMATION REVIEWED IN THIS REPORT IT IS UNLIKELY THAT THERE WAS A MANUFACTURING FAULT. PATIENT X-RAYS PROVIDED WERE NOT RELEVANT TO THIS REPORTING. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

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

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE REC'D 7/16/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM METALLOSIS AND ELEVATED LEVELS OF COBALT AND CHROMIUM. UPDATE REC'D 10/16/2014- PFS AND MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PRIMARY OPERATIVE NOTE INDICATED A CRACK OCCURRED IN THE CALCAR WHEN INSERTING THE STEM. DURING THE REVISION OPERATION THERE WAS METALLOSIS AROUND THE JOINT AND ON THE TRUNNION. INCREASED METAL IONS WERE ALSO CONFIRMED AS ALLEGED PER LITIGATION. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 11/10/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722391 SUMMIT DUOFIX TAP SZ5 STD OFF HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US CT7C71000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention