BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM STM ST,36+6L NK,11X16X150

    MDR report key: 2924447 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-00690
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    August 20, 2011
    Report Date
    December 26, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    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 2546061, 2515289, AND 2559835. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ONE ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2518087 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

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT WAS REVISED BECAUSE OF SEVERE PAIN, DISCOMFORT, AND LOSS OF MOBILITY. PATIENT IS A RESIDENT OF (B)(6). UPDATE - (B)(4) 2012 - PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE PATIENT WAS REVISED DUE TO PAIN. THE SLEEVE AND STEM WERE ADDED TO THE COMPLAINT. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29598 SROM STM ST,36+6L NK,11X16X150 TOTAL HIP REPLACEMENT MRA DEPUY ORTHOPAEDICS INC US 2559835

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other