BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 46

    MDR report key: 3230514 · Received July 16, 2013

    Report

    Report Number
    1818910-2013-21356
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 26, 2008
    Report Date
    July 3, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    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

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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

    REASON(S) FOR REVISION: UNKNOWN.

    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 HIP RESURFACING SYSTEM (LEFT); ASR HIP RESURFACING SYSTEM (RIGHT). BI-LATERAL REVISION. UPDATE RECEIVED: 18TH JUNE 2013 - ADDED SIDE HIP: RIGHT, AMENDED IMPLANT DATE: (B)(6) 2005 AND ADDED PRODUCTS: BOTH. REASON(S) FOR REVISION: UNKNOWN. BI-LATERAL PATIENT - THIS COM IS FOR THE RIGHT SIDE REVISION. PLEASE SEE (B)(4) FOR THE LEFT SIDE REVISION. UPDATE RECEIVED 21ST MARCH 2014. REVISION DATE AMENDED AS (B)(6) REVISION DATE WAS UNCONFIRMED. HOSPITAL NAME AMENDED. REASON FOR REVISION ADDED. NEW FIELDS COMPLETED. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    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 HIP RESURFACING SYSTEM (LEFT); ASR HIP RESURFACING SYSTEM (RIGHT) BI-LATERAL REVISION. UPDATE RECEIVED: 18TH JUNE 2013 - ADDED SIDE HIP: RIGHT, AMENDED IMPLANT DATE: (B)(6) 2005 AND ADDED PRODUCTS: BOTH. REASON(S) FOR REVISION: UNKNOWN. BI-LATERAL PATIENT - THIS COM IS FOR THE RIGHT SIDE REVISION. PLEASE SEE (B)(4) FOR THE LEFT SIDE REVISION. UPDATE RECEIVED 21ST MARCH 2014. REVISION DATE AMENDED AS (B)(6) REVISION DATE WAS UNCONFIRMED. HOSPITAL NAME AMENDED. REASON FOR REVISION ADDED. NEW FIELDS COMPLETED. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. SURGEON CONFIRMATION FORM RECEIVED 3RD JULY 2014. ADDITIONAL HOSPITALS, SURGEON NAME AND TITLE ADDED. ADDITIONAL REASON FOR REVISION ADDED AND COMPLAINT CATEGORY AMENDED. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328208 TOTAL ASR FEM IMP SIZE 46 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 1954382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention