BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 49

    MDR report key: 2418054 · Received January 17, 2012

    Report

    Report Number
    1818910-2012-01543
    Event Type
    Injury
    Date Received
    January 17, 2012
    Date of Event
    May 4, 2009
    Report Date
    May 20, 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
    GM
    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.

    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

    ASR REVISION. ASR HIP RESURFACING SYSTEM - RIGHT. REASON(S) FOR REVISION: COMPONENT LOOSENING (RESURFACING HEAD), OTHER REASONS PAIN DISLOCATION.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION, ASR HIP RESURFACING SYSTEM - RIGHT, REASON(S) FOR REVISION: COMPONENT LOOSENING (RESURFACING HEAD), OTHER REASONS PAIN & DISLOCATION. SYSTEM CHANGED TO XL AND FOLLOWING PRODUCTS REMAIN IN SITU : 999804956 ASR ACETABULAR IMPLANT 56 1203276, 999890149 DEPUY ASR XL FEM IMP SIZE 49 2622656, 999800102 ASR XL TAP SLV ADAP 12/14+2 2653149. UPDATE RECEIVED 14TH MARCH, 2014. SURGERY DATE AMENDED. EMAIL INCLUDES THIS RECORD - CLAIM WAS DELETED FROM DATABASE IN ERROR AND THEN RE-ENTERED. UPDATE RECEIVED 27TH MARCH 2014: SURGEON ADDED.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(6). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR HIP RESURFACING SYSTEM - RIGHT. REASON(S) FOR REVISION: COMPONENT LOOSENING (RESURFACING HEAD), OTHER REASONS PAIN & DISLOCATION. SYSTEM CHANGED TO XL AND FOLLOWING PRODUCTS REMAIN IN SITU : 999804956 ASR ACETABULAR IMPLANT 56 1203276. 999890149 DEPUY ASR XL FEM IMP SIZE 49 2622656. NON DEPUY STEM. 999800102 ASR XL TAP SLV ADAP 12/14+2 2653149. UPDATE RECEIVED 14TH MARCH, 2014. SURGERY DATE AMENDED. EMAIL INCLUDES THIS RECORD - CLAIM WAS DELETED FROM DATABASE IN ERROR AND THEN RE-ENTERED. UPDATE RECEIVED 27TH MARCH 2014: SURGEON ADDED. UPDATE RECEIVED: 20TH MAY 2014 - ADDED HOSPITAL: (B)(6), QUERY AND RESPONSE DOCUMENT, CLARIFICATION/CONFIRMATION DOCUMENT AND ADVISED XL STEM IMPLANT WAS NON DEPUY STEM, BUT THESE XL PRODUCTS HAVE NOT BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 1135400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention