BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 51

    MDR report key: 3780796 · Received April 30, 2014

    Report

    Report Number
    1818910-2014-17744
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 16, 2014
    Report Date
    August 11, 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

    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. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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

    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. 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

    ASR REVISION. LEFT ASR XL. REASON(S) FOR REVISION: ALVAL/SOFT TISSUE REACTION. UPDATE -MW FIELDS, RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM CRAWFORDS SPREADSHEET DATED 15TH APRIL 2014. UPDATE CONFIRMATION OF IMPLANT DATES RECEIVED FROM CRAWFORDS (B)(6) 2014. DOI (B)(6) 2008. UPDATE - JUNE 15, 2017 ADDITIONAL INFORMATION RECEIVED FROM CRAWFORD: CORRECT SURGERY DATE: (B)(6) 2008. THIS COMPLAINT WAS UPDATED ON JUNE 22, 2017. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION, LEFT, ASR XL, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE -MW FIELDS, RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM CRAWFORDS SPREADSHEET DATED (B)(6) 2014.

    Description of Event or Problem · 1

    ASR REVISION; LEFT; ASR XL. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. UPDATE -MW FIELDS, RECEIVED CONFIRMATION THAT REVISION HAS TAKEN PLACE. TAKEN FROM (B)(4) DATED 15TH APRIL 2014. UPDATE CONFIRMATION OF IMPLANT DATES RECEIVED FROM (B)(4) 11 AUG 2014. DOI (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260662 DEPUY ASR XL FEM IMP SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2646344

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention