BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ7 HI OFF

    MDR report key: 2972091 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-03910
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 4, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS OF ANY KIND AGAINST THE A4BGD1 LOT CODE. ADDITIONALLY, RESEARCH USING THE AS400 SYSTEM INDICATES THAT SEVERAL OTHER DEVICES FROM THE REPORTED LOT HAVE BEEN DELIVERED AND ARE CONSIDERED SUCCESSFULLY IMPLANTED AS NO OTHER REPORTS HAVE BEEN RECEIVED. IT IS KNOWN THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE PERFORMED INVESTIGATION AND LACK OF PRODUCT TO EXAMINE, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. 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

    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 PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN, THE INABILITY TO WALK AND PERFORM DAILY ACTIVITIES, ELEVATED METAL ION LEVELS, AND HETEROTOPIC OSSIFICATION. **UPDATE** 08/06/2012 - PLAINTIFF FACT SHEET WAS RECEIVED. THE PRODUCT/LOT WAS UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. **UPDATE**11/06/2012-SALES REP REPORTED REVISION SURGERY DUE TO HIGH METAL COUNT AND PAIN. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DOR: (B)(6) 2012 **UPDATE**02/04/2013-MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATES PAIN, EVIDENCE FOR ACETABULAR CUP LOOSENING, EXTENSIVE HETEROTOPIC OSSIFICATION, AND ALSO NOTED EVIDENCE OF TRUNNION CORROSION INTEROPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75689 SUMMIT POR TAPER SZ7 HI OFF STEM MRA DEPUY WARSAW A4BGD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention