BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18B-LRG

    MDR report key: 3637333 · Received February 20, 2014

    Report

    Report Number
    1818910-2014-13021
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    July 16, 2012
    Report Date
    January 30, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LPH
    PMA / PMN Number
    K934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    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. 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

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. REVISION OPERATIVE NOTE INDICATED CORROSION. REVISION DISCHARGE RECORDS INDICATE THAT CULTURES CAME BACK POSITIVE FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108905 S-ROM*SLEEVE PRX ZTT, 18B-LRG S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE LPH DEPUY IRELAND 9616671 1809795

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention