BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 20D-SML

    MDR report key: 9617626 · Received January 22, 2020

    Report

    Report Number
    1818910-2020-02512
    Event Type
    Injury
    Date Received
    January 22, 2020
    Report Date
    January 8, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295175339
    PMA / PMN Number
    K934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> 2153493. (B)(4). DEVICE HISTORY REVIEW ==> REVIEW OF THE DEVICE MANUFACTURING RECORDS FOUND NO RELATED DEVIATIONS OR ANOMALIES. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGED NUMBNESS IN LEGS AND FEET AFTER FIRST REVISION. ADDED CUP, APEX HOLE ELIMINATOR AND SLEEVE TO CAPTURE THE ALLEGATION. DOI: (B)(6) 2017 (LINER & HEAD); DOI: (B)(6) 2009 (CUP, APEX & SLEEVE); DOR: NONE REPORTED RIGHT HIP. PLEASE SEE (B)(4) RIGHT HIP 1ST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78456 S-ROM*SLEEVE PRX ZTT, 20D-SML S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE LPH DEPUY ORTHOPAEDICS INC US 55-0533 2153493 10603295175339

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention