BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ7 STD OFF

    MDR report key: 2926569 · Received January 23, 2013

    Report

    Report Number
    1818910-2013-00692
    Event Type
    Injury
    Date Received
    January 23, 2013
    Report Date
    December 26, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE LOT CODES 2176015 AND Y3BBY1. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST BOTH LOT CODES 2120336 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED PAIN, SWELLING, LACK OF MOBILITY, DAMAGE TO SURROUNDING TISSUE AND BONE CAUSED BY INFLAMMATION, METALLOSIS, PSEUDOTUMOURS, BURSITIS, AND BONE EROSION. (B)(6). **UPDATE**(B)(4) 2012 - PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE WAS A BONE CRACK NOTED IN OPERATIVE NOTES. THE STEM WAS ADDED TO THE COMPLAINT. PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31857 SUMMIT POR TAPER SZ7 STD OFF TOTAL HIP REPLACEMENT LPH DEPUY ORTHOPAEDICS INC US Y3BBY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other