BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL SLV ADAP 12/14 +8

    MDR report key: 6767317 · Received August 4, 2017

    Report

    Report Number
    1818910-2017-22279
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    August 8, 2011
    Report Date
    July 6, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    ASR REVISION: ASR XL ACETABULAR SYSTEM (BILATERAL), REASON(S) FOR REVISION: PAIN. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4).   REASON FOR ORIGINAL COMPLAINT ASR REVISION, ASR XL ACETABULAR SYSTEM (BILATERAL), REASON(S) FOR REVISION: PAIN. UPDATE FROM (B)(6)'S SPREADSHEET (B)(6) 2011: DATE OF REVISION ADDED, SURGEON, HOSPITAL CHANGED UPDATE: REASON FOR REVISION ADDED, DATES ON THIS DINT RELATE TO THE REVISION OF THE RIGHT HIP AS DO PRODUCTS 1881691 (LOT NUMBER) AND 1221327 (LOT NUMBER), VERIFIED BY (B)(6)S UPDATE SPREADSHEET 2 DEC 2011. UPDATE JULY 6, 2017: ADDITIONAL INFORMATION RECEIVED FROM (B)(6). ADDED REASON FOR REVISION: PAIN AND FACILITY NAME. THIS COMPLAINT WAS UPDATED ON JULY 17, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546726 ASR XL SLV ADAP 12/14 +8 HIP FEMORAL STEM/SLEEVE JDI DEPUY INTERNATIONAL LTD. 8010379 1221327

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention