BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*STM STD,42 NK,18X13X160

    MDR report key: 3230226 · Received July 16, 2013

    Report

    Report Number
    1818910-2013-21349
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    January 22, 2008
    Report Date
    June 21, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 1014133 AND XXX36. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 1057426 AND 1004203 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. -LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN, AND DISCOMFORT, LOOSENING OF HIP IMPLANT, AND DIFFICULTY WITH DAILY LIVING. DOI: (B)(6) 2004 - DOR: (B)(6) 2008 (LEFT HIP); PATIENT IS A RESIDENT (B)(6). UPDATE: (B)(4) 2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE (B)(4) 2013 - UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, CORROSION AND STEM/SLEEVE LOOSENING WAS DISCOVERED. PART/LOT WAS PROVIDED. A STEM AND SLEEVE HAVE BEEN ADDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328861 S-ROM*STM STD,42 NK,18X13X160 SLEEVE JDI DEPUY ORTHOPAEDICS INC US 1014133

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention