BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 40MM M SPEC+3

    MDR report key: 2929745 · Received January 25, 2013

    Report

    Report Number
    1818910-2013-02204
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    October 28, 2011
    Report Date
    December 27, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RELATED REPORTS FOR THE LOT CODES 2251243, 2253172, 2290690, 2465269, EN4FF1000, 3070342, AND 2294930. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2452680 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS 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

    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

    (B)(4)

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: THE PATIENTS HIPS ARE DEFECTIVE AND HAVE CAUSED DAMAGE TO HER HIP JOINT AND HER BODY UPDATE: (B)(4) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT HAD MULTIPLE SURGERIES FOR BOTH HIPS. LEFT HIP: DOI: (B)(6) 2006; DOR: (B)(6) 2010 BECAUSE OF PAIN AND LOSS OF ABDUCTORS. RIGHT HIP: DOI: (B)(6) 2007; DOR: (B)(6) 2010 FOR PAIN, ABDUCTOR REPAIR AND LOOSE STEM, DOR: (B)(6) 2010 FOR PAIN, DISLOCATION, AND ABDUCTOR REPAIR. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35605 11/13 S-ROM 40MM M SPEC+3 HEAD LPH DEPUY ORTHOPAEDICS, INC. 1818910 3070342

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention