BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER SLEEVES 12/14 +2

    MDR report key: 4091685 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28098
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN AND THAT THE SYSTEM POPS AND LOCKS UP. UPDATE: (B)(4) 2013 NEW LITIGATION PAPERS RECEIVED. COMMENT: THERE IS A DOI DISCREPANCY BETWEEN NEW LITIGATION AND ORIGINAL LITIGATION, THE DOI FROM THE ORIGINAL LITIGATION WILL REMAIN, AS IT CORRESPONDS WITH THE DATE OF SERVICE LISTED IN THE INVOICE. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE IF NEEDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE (B)(4) - DER RECEIVED VIA SALES REP. UPDATED DOR ((B)(6) 2014), PATIENT AGE, DOB, HEIGHT AND WEIGHT, SURGEON NAME AND SALES REP INFORMATION. UPDATED CUP AND HEAD DETAILS AND ADDED STEM AND SLEEVE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573506 ADAPTER SLEEVES 12/14 +2 HIP OTHER IMPLANT KWA DEPUY INTERNATIONAL LTD.-8010379 2881216

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention