BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 48

    MDR report key: 2961508 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-02502
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 6, 2013
    Report Date
    September 26, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 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

    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

    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4) REASON FOR ORIGINAL COMPLAINT - ASR REVISION, LEFT, ASR XL, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. LOT NUMBER 2300587 INCORRECT, 2300687 USED INSTEAD . UPDATE - MARKED AS LEGAL, TAKEN FROM (B)(6) EMAIL DATED 23RD JULY 2014. UPDATE RECEIVED 26TH SEPTEMBER 2014. REVISION DATE AMENDED. EXPIRY DATES ADDED. THIS IS A BILATERAL PATIENT. 13TH OCTOBER 2014: PATIENT CONFIRMED TO BE UNILATERAL. REVISION DATE AMENDED.

    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. LEFT ASR XL. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. LOT NUMBER 2300587 INCORRECT, 2300687 USED INSTEAD. UPDATE - MARKED AS LEGAL, TAKEN FROM (B)(6) EMAIL DATED 23RD JULY 2014.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT HIP; REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66094 TOTAL ASR ACET IMP SIZE 48 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1840536

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention