BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS 10/13.5 R BOW

    MDR report key: 3113826 · Received May 15, 2013

    Report

    Report Number
    1818910-2013-17137
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    October 30, 2010
    Report Date
    April 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K060581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 YFW71 AND WR3HY1001. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2346301 AND 2173616 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY A MEDICAL PROFESSIONAL. 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.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: LITIGATION ALLEGES THAT THE PATIENT SUFFERS PAIN. DOI: (B)(6) 2007- DOR: NONE REPORTED (RIGHT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(6) 2013. MEDICAL RECORDS RECEIVED FROM LEGAL, THE PATIENT WAS REVISED BECAUSE OF STEM SUBSIDENCE, OSTEOLYSIS, AND CUP MALPOSITIONING.

    Description of Event or Problem · 1

    PPF ALLEGES DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215465 SOL SYS 10/13.5 R BOW SOLUTION STEM IMPLANTS : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US AT4GN1000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention