BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8214324 · Received January 3, 2019

    Report

    Report Number
    1818910-2019-79827
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    November 10, 2014
    Report Date
    December 6, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    UDI-DI
    10603295178200
    PMA / PMN Number
    K954935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PPF AND STICKER SHEETS RECEIVED. PPF ALLEGED FRACTURE BONE AND LOOSENING OF THE STEM. THE POLY LINER, METAL HEAD, AND STEM WERE REPORTED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATION. UNKNOWN HIP IMPLANT WAS ALSO ADDED TO THE IMPACTED PRODUCT SINCE THERE WAS NO INFORMATION PROVIDED IN THE PPF ON WHAT BONE ARE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5435 SROM STM ST,36+6L NK,11X16X150 S-ROM HIP SYSTEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. 1818910 1890678 10603295178200

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention