BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 2141489 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-10495
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    January 6, 2011
    Report Date
    April 16, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE US AT THIS TIME. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. 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 (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION BI-LATERAL ASR XL ACETABULAR SYSTEM (RIGHT); ASR XL ACETABULAR SYSTEM (LEFT). REASON(S) FOR REVISION: PAIN. RIGHT HIP: SURGERY DATE: (B)(6) 2008. REVISION DATE: (B)(6) 2011. SURGEON: DR (B)(6). ON 7/12 - UPDATE FROM (B)(6) SPREADSHEET DATED 2 DECEMBER 2011- ADDED PRODUCT CODE AND LOT NUMBER. UPDATE RECEIVED: 16TH APRIL 2014 - ADDED LEFT SIDE HIP REVISION DATE: (B)(6) 2011, ADDED PATIENT NAME, ADDED PATIENT ID (INITIALS), ADDED PATIENT DATE OF BIRTH, ADDED PATIENT GENDER, ADDED PATIENT AGE, ADDED PATIENT RIGHT AND LEFT SIDE HIP STEM LOT NUMBERS, ADDED SURGEON'S TITLE: DR, ADDED HOSPITAL AREA: (B)(6), ADDED LEFT SIDE IMPLANT DATE: (B)(6) 2007, AMENDED RIGHT SIDE IMPLANT DATE: (B)(6) 2008 AND CLARIFIED DETAILS. LEFT HIP: SURGERY DATE: (B)(6) 2007. REVISION DATE: (B)(6) 2011. REASON(S) FOR REVISION: PAIN. RIGHT HIP: SURGERY DATE: (B)(6) 2008. REVISION DATE: (B)(6) 2011. REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    THE PT WAS REVISED TO ADDRESS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL, LTD. NA 2183119

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention