BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 49

    MDR report key: 4233689 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31378
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    March 15, 2013
    Report Date
    November 19, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    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

    ADDITIONAL NARRATIVE: 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. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. ` 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.

    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) 2013. HIP(S) TO BE REVISED: LEFT. TYPE OF HIP REPLACEMENT PRODUCT: ASR RESURFACING. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. BI-LATERAL PATIENT FOR RIGHT HIP SEE (B)(4). UPDATE - ADDED REVISION DATE INTO CORRECT BOX. TAKEN FROM CLAIMSUITE DATED 1ST NOV 2014. REV DATE - (B)(6) 2013. UPDATE - AMENDED EXPIRY AND MANUFACTURING DATES FOR THE HEAD ON (B)(6) 2014, EXPIRY DATE - 29TH MAY 2012, MANUFACTURING DATE - 4TH JUNE 07.

    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 TO TAKE PLACE ON (B)(6) 2013. HIP(S) TO BE REVISED: LEFT. TYPE OF HIP REPLACEMENT PRODUCT: ASR RESURFACING. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. BI-LATERAL PATIENT FOR RIGHT HIP SEE (B)(4). UPDATE - ADDED REVISION DATE INTO CORRECT BOX. TAKEN FROM CLAIMSUITE DATED 1ST NOV 2014. REV DATE - (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714498 TOTAL ASR FEM IMP SIZE 49 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2394257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention