BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM ST,36+8L NK,18X13X160

    MDR report key: 2881392 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28210
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    DEPUY IRELAND
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: 11/27/2012 - ADDITIONAL LITIGATION PAPERS RECEIVED 11/05/2012 AND ATTACHED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: 12/17/2012 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED 11/20/2012 WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: 11/20/2012 - PPD WAS RECEIVED FROM LEGAL. IT IS NOTED ON THE PRIMARY OPERATIVE REPORT THAT THE LAST 1 CM OF THE STEM WAS DIFFICULT TO GO DOWN IN THE SLEEVE, CONSEQUENTLY ON IMPACTION THE ANTERIOR SPLIT PROPAGATED TO THE MID PORTION OF THE STEM. THE FEMORAL STEM AND SLEEVE WERE ADDED TO THE COMPLAINT. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). IT WAS REPORTED THAT THE STEM WAS HARD TO PROPERLY SEAT AT THE PRIMARY IMPLANTATION. HOWEVER, IT WAS FURTHER REPORTED THAT THE STEM HAS EXCELLENT STABILITY POST IMPACTION. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO SIMILAR REPORTS AGAINST THE STEM OR SLEEVE PRODUCT/LOT CODE COMBINATIONS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE ASR RIGHT HIP IMPLANT CAUSED PAIN IN THE PATIENT. LITIGATION FURTHER ALLEGES THAT THE PATIENT SUFFERED DISABILITY, PHYSICAL IMPAIRMENT, AND DISFIGUREMENT. LITIGATION FURTHER ALLEGES THAT THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD AS DETERMINED FROM BLOOD TESTS. UPDATE: (B)(6) 2012 - ADDITIONAL LITIGATION PAPERS RECEIVED (B)(6) 2012 AND ATTACHED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2012 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED (B)(6) 2012 WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2012 - PPD WAS RECEIVED FROM LEGAL. IT IS NOTED ON THE PRIMARY OPERATIVE REPORT THAT THE LAST 1 CM OF THE STEM WAS DIFFICULT TO GO DOWN IN THE SLEEVE, CONSEQUENTLY ON IMPACTION THE ANTERIOR SPLIT PROPAGATED TO THE MID PORTION OF THE STEM. THE FEMORAL STEM AND SLEEVE WERE ADDED TO THE COMPLAINT.

    Description of Event or Problem · 1

    ASR SUPPLEMENTAL INFO RECEIVED. AFTER REVIEW OF THE INFORMATION FOR MDR REPORTABILITY, THE ASR TAPER SLEEVE IS BEING ADDED FOR THE ALLEGED HIGH METAL ION LEVELS (NO LABS PROVIDED). NO DATE OF REVISION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SROM*STM ST,36+8L NK,18X13X160 HIP FEMORAL STEM/SLEEVE JDI DEPUY IRELAND 2970819

    Patients

    Seq Age Sex Outcome Treatment
    1 Other