BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPER SLEEVE ADAPTER 12/14 +2

    MDR report key: 7165135 · Received January 4, 2018

    Report

    Report Number
    1818910-2018-50229
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    August 26, 2011
    Report Date
    December 6, 2017
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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 (B)(4). 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

    NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT NUMBER (B)(4). ASR REVISION; ASR XL - LEFT; REASON(S) FOR REVISION: PAIN; INVALID LOT NUMBER PROVIDED FOR STEM - BF5JC1000. DOI: (B)96) 2007; DOR: (B)(6) 2011; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8164 TAPER SLEEVE ADAPTER 12/14 +2 ASR HIP SYSTEM : HIP FEMORAL SLEEVE KWA DEPUY INTERNATIONAL LTD. 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention