BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM STD36+21CR 18X13X160

    MDR report key: 2991646 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-13269
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 10, 2007
    Report Date
    February 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MRA
    PMA / PMN Number
    K910664
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM INFECTION. UPDATE 04/29/2013 - PFS AND MEDICAL RECORDS RECEIVED. AN INVOICE SEARCH IDENTIFIED THE PART/LOT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 2149748, 1005247, 1156192, X5EHG1. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES YE6AX4 AND AT1BA1 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE. THE COMPLAINT IS NOT PRODUCT RELATED. THE SURGEON WHO PERFORMED THE LAST TWO SURGERIES CONCURS THAT AN IUD PLACEMENT PRECIPITATED THE INFECTION. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95675 SROM*STM STD36+21CR 18X13X160 FEMORAL STEM MRA DEPUY ORTHOPAEDICS INC US 1005247

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention