BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 58

    MDR report key: 3122363 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-06076
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    June 20, 2012
    Report Date
    May 30, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    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. REF. (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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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.

    Additional Manufacturer Narrative · 1

    (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

    ASR REVISION; ASR XL ACETABULAR SYSTEM - LEFT HIP; REASON FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    REASON FOR REVISION: NOISE.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER DINT (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL ACETABULAR SYSTEM - LEFT. REASON(S) FOR REVISION: UNKNOWN. UPDATE RECEIVED: 20TH AUGUST 2013 - ADDED REVISION REASON: NOISE. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER, ADDED ADDITIONAL HOSPITAL AND FILED OUT MW FIELDS. TAKEN FROM (B)(6) SPREADSHEET DATED 30TH MAY 2014. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223564 TOTAL ASR ACET IMP SIZE 58 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2463818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D