BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT DUOFIX TAP SZ5 HI OFF

    MDR report key: 3013403 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-04359
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 20, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    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

    UPDATE: 03/12/2013 - LITIGATION RECEIVED 03/08/2013 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. DOB ADDED. LITIGATION ALLEGES PATIENT HAD PAIN, PHYSICAL INJURY, BODILY IMPAIRMENT AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: 02/20/2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION CORROSION WAS FOUND AROUND THE TRUNNION OF THE FEMORAL COMPONENT. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH/REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE NECESSARY PRODUCT CODE/LOT CODE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN AND HIGH COBALT LEVELS. **UPDATE** (B)(4) 2013 - LITIGATION RECEIVED (B)(4) 2013 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. DOB ADDED. LITIGATION ALLEGES PATIENT HAD PAIN, PHYSICAL INJURY, BODILY IMPAIRMENT AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE** (B)(4) 2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION CORROSION WAS FOUND AROUND THE TRUNNION OF THE FEMORAL COMPONENT. **UPDATE** (B)(4) 2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION FOR THE FEMORAL STEM. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN AND HIGH COBALT LEVELS. (B)(4) 2013 - LITIGATION RECEIVED (B)(4) 2013 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. DOB ADDED. LITIGATION ALLEGES PATIENT HAD PAIN, PHYSICAL INJURY, BODILY IMPAIRMENT AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT. (B)(4) 2013 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION CORROSION WAS FOUND AROUND THE TRUNNION OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116746 SUMMIT DUOFIX TAP SZ5 HI OFF STEM LPH DEPUY WARSAW B95CT1000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR