BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 2936117 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-01559
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    August 12, 2015
    Report Date
    August 13, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    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 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.

    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. (B)(4).

    Description of Event or Problem · 1

    ASR REVISION; ASR XL ACETABULAR SYSTEM RIGHT HIP; REASON(S) FOR REVISION: UNKNOWN.

    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 TO TAKE PLACE ON (B)(6) 2011. ASR XL ACETABULAR SYSTEM RIGHT HIP. REASON(S) FOR REVISION: UNKNOWN . UPDATE- ADDED A SLEEVE, REVISION DATE, SURGERY DATE TAKEN FROM CLAIMSUITE DATED 18TH DECEMBER 2012 . 13 AUG 2015 - UPDATE - PATIENT IS BILATERAL - FOR LEFT HIP SEE (B)(4). RCVD REASONS FOR REVISION: ALVAL, PAIN, HIGH MENTAL IONS, LIMITED RANGE OF MOVEMENT, ADDED S-ROM SLEEVE, PATIENT NAME, DOB, UPDATE CLAIMSUITE STATES REVISION DATE AS (B)(6) 2015 - QUERYING AS STATES BOTH LEFT AND RIGHT WERE REVISED AT THE SAME TIME - YET RIGHT REVISION WAS TO TAKE PLACE ON (B)(6) 2011 AS RECORDED ON DINT SYSTEM (B)(4). 17 AUG 2015 - RCVD COPY OF ANAESTHETISTS INVOICE THAT STATES BILATERAL HIP REVISION ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40697 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2237887

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention