BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ5 STD OFF

    MDR report key: 4142117 · Received October 4, 2014

    Report

    Report Number
    1818910-2014-29414
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    December 30, 2013
    Report Date
    September 12, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK011489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE METAL HEAD AND METAL LINER PROVIDED PRODUCT AND LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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).

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE REC'D 7/14/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM NUMBNESS AND DIFFICULTY AMBULATING. UPON REVISION, THE SURGEON NOTED "BULGING OF THE PERIARTICULAR SPACE" WHERE TENDON REPAIR HAD BEEN PERFORMED, POSSIBLE CORROSION/ FRETTING, INFLAMMATION, ALVAL, AND METALLOSIS. AN INVOICE SEARCH WAS PERFORMED AND WAS UNSUCCESSFUL. THEREFORE, WE ARE NOT CURRENTLY REPORTING ADDITIONAL PRODUCTS FOR THE CORROSION. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE ACCORDINGLY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE MDR DECISION. UPDATE REC'D 9/12/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED PAIN, CORROSION AT THE STEM/HEAD JUNCTION, BONE LOSS AROUND THE STEM, AND CIRCUMFERENTIAL SCUFFING ON THE FEMORAL HEAD OF UNKNOWN ETIOLOGY. THERE WAS NO MENTION OF METALLOSIS OR ALVAL AS LITIGATION ALLEGED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 10/4/2014.

    Description of Event or Problem · 1

    PPF ALLEGES ABDUCTOR MUSCLE REPAIR AND METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621320 SUMMIT DUOFIX TAP SZ5 STD OFF HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US CA4LD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention