BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM -3

    MDR report key: 4863866 · Received June 23, 2015

    Report

    Report Number
    1818910-2015-24161
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    April 29, 2013
    Report Date
    May 29, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). 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 ALLEGES PAIN, DISCOMFORT, AND INCREASED METAL IONS. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED INCREASED METAL IONS AND NON-UNION OF GREATER TROCHANTER. THIS NON-UNION IS FROM A PREVIOUS TROCHANTERIC OSTEOTOMY. LAB RESULTS CONFIRMED THE HIGH METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407137 S-ROM M HEAD 36MM -3 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2709202

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention