BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL AUGMENT

    MDR report key: 7274644 · Received February 15, 2018

    Report

    Report Number
    1818910-2018-53500
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    January 19, 2018
    Report Date
    January 18, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY : THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-001226. ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT. 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

    REVISION TOTAL HIP REPLACEMENT, (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2012. REVISION FOR: WEAR BETWEEN THE STEM TAPER AND FEMORAL HEAD. X-RAYS AVAILABLE - UPLOADED TO UNITY. FEMALE PATIENT INITIALS CT, DOB (B)(6). UNKNOWN JRN: (B)(4) - DEPUY ASR TOTAL ACETABULAR IMPLANT LOT 1153442. UNKNOWN JRN: (B)(4) - DEPUY ASR UNIPOLAR FEMORAL IMPLANT LOT 1199936.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116362 UNKNOWN HIP FEMORAL AUGMENT HIP FEMORAL AUGMENT JDI DEPUY INTERNATIONAL LTD. 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention