BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ4 STD OFF

    MDR report key: 3864636 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20623
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    July 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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.DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    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.

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION, LEFT, ASR XL, REASON(S) FOR REVISION: PAIN. LOT NUMBER FOR STEM BN2F61000 INVALID BT2F61000 USED INSTEAD.

    Description of Event or Problem · 1

    ASR REVISION.LEFT.ASR XL.REASON(S) FOR REVISION: PAIN.LOT NUMBER FOR STEM BN2F61000 INVALIVD BT2F61000 USED INSTEAD(B)(4)

    Description of Event or Problem · 1

    ASR REVISION. LEFT. ASR XL. REASON(S) FOR REVISION: PAIN. LOT NUMBER FOR STEM BN2F61000 INVALID BT2F61000 USED INSTEAD. UPDATE - ADDED DCGI REF, PATIENT AGE, GENDER, INITIALS AND ATTACHED (B)(6) REPORT. TAKEN FROM (B)(6) REPORT DATED 11TH JULY 2014. UPDATE - RECEIVED IMPLANT DATE, TAKEN FROM EMAIL DATED 24TH JULY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341329 SUMMIT POR TAPER SZ4 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US BT2F61000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention