BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM LINR MSER, 0 DEG, 28MM C

    MDR report key: 1871272 · Received October 15, 2010

    Report

    Report Number
    1818910-2010-06485
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K951000
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PROVIDED PRODUCT/LOT CODE COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE, HOWEVER, IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH A COMPETITOR MANUFACTURED PRODUCT. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS DISLOCATION OF A DEPUY LINER USED IN CONJUNCTION WITH A COMPETITOR'S STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM LINR MSER, 0 DEG, 28MM C 87LPH LPH DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA SC108099

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention