BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 46

    MDR report key: 2248054 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-14610
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    May 11, 2011
    Report Date
    August 26, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816/2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    PT WAS REVISED FOR UNK REASONS.

    Description of Event or Problem · 1

    REASON FOR REVISION ALVAL.

    Description of Event or Problem · 1

    REASON FOR REVISION IS NOT ALVAL. REASON FOR REVISION IS LOOSENING OF IMPLANT.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION RECOMMENDED. ASR XL ACETABULAR SYSTEM (RIGHT) AND ASR XL ACETABULAR SYSTEM (LEFT) - BI-LITERAL. UPDATE RECEIVED 29 JULY 2013 - DOR, PRODUCT CODES, LOT NUMBERS, REASON FOR REVISION. UPDATE RECEIVED 26 AUGUST 2014. CORRECT REVISION DATE ATTRIBUTED TO LEFT HIP. CORRECT REVISION REASONS ATTRIBUTED TO THE RIGHT HIP. CORRECT HIP SIDE ATTRIBUTED TO PRODUCTS. REVISION DATE ADDED FOR THE RIGHT HIP. REASON FOR REVISION ADDED FOR THE LEFT HIP. NEW FIELDS COMPLETED. LEFT HIP REVISION: (B)(6) 2011: 999800206 / 1221341; 999804146 / 1203277; 999890141 / 1885180. REASON(S) FOR REVISION: COMPONENT LOOSENING (CUP). RIGHT HIP REVISION: (B)(6) 2011: 999890141 / 1929077; 999800206 / 1221341; 999804146 / 1839873. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. QUERY CONFIRMATION RECEIVED 1ST SEPTEMBER 2014. COMPONENT LOOSENED CONFIRMED TO BE THE CUP. IMPLANT DATES CONFIRMED. LEFT HIP IMPLANT DATE: (B)(6) 2006. RIGHT HIP IMPLANT DATE: (B)(6) 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 46 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. NA 1839873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention