BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 46

    MDR report key: 2778880 · Received October 9, 2012

    Report

    Report Number
    1818910-2012-76801
    Event Type
    Injury
    Date Received
    October 9, 2012
    Date of Event
    December 4, 2012
    Report Date
    May 19, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    Removal / Correction Number
    1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION;RIGHT;ASR HIP RESURFACING;REASON(S) FOR REVISION: PAIN.

    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. RIGHT ASR HIP RESURFACING. REASON(S) FOR REVISION: PAIN. INCORRECT LOT NUMBER SUPPLIED FOR THE HEAD 2002376. UPDATE- UPDATED DATE OF REVISION TAKEN FROM (B)(6) DATED 2ND NOV 2012. REVISION DATE - (B)(6) 2012. UPDATE - ADDED REVISION DATE, AMENDED HIP SIDE. TAKEN FROM (B)(6) EMAIL DATED 7TH MAY 2014. LEFT SIDE (NOT RIGHT AS PREVIOUSLY STATED).

    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. RIGHT. ASR HIP RESURFACING. REASON(S) FOR REVISION: PAIN. INCORRECT LOT NUMBER SUPPLIED FOR THE HEAD 2002376. UPDATE- UPDATED DATE OF REVISION TAKEN FROM CLAIMSUITE DATED 2ND NOV 2012. REVISION DATE - (B)(6) 2012. UPDATE - ADDED REVISION DATE, AMENDED HIP SIDE. TAKEN FROM (B)(6) EMAIL DATED 7TH MAY 2014. LEFT SIDE (NOT RIGHT AS PREVIOUSLY STATED). UPDATE RECEIVED: 28TH MAY 2014 - ADDED UNKNOWN TO HEAD LOT NUMBER FIELD AS LOT NUMBER PROVIDED FOR HEAD IS INVALID, ADDED SURGEON NOTES, ADDED FURTHER REASON FOR REVISION: ADVERSE SOFT TISSUE REACTION: BROWN NECROTIC TISSUE, POSSIBLE ALVAL AND DEBRIS AND ADDED SURGEONS FORENAME: (B)(6).

    Description of Event or Problem · 1

    UPDATE - ADDED CORRECT LOT NUMBER AND MANUFACTURING DATE FOR HEAD. ADDED ALL EXPIRY DATES. TAKEN FROM EMAIL DATED 19TH MAY 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 46 ASR TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL LTD. 8010379 2002378

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention