BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 46

    MDR report key: 4999184 · Received August 13, 2015

    Report

    Report Number
    1818910-2015-27808
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    October 6, 2015
    Report Date
    October 27, 2015
    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
    ATTORNEY

    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

    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.

    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.

    Additional Manufacturer Narrative · 1

    NEW LEGAL CLAIM RECEIVED FROM (B)(6) UNKNOWN SYSTEM UNKNOWN SIDE PRODUCT DETAILS UNAVAILABLE NO CONFIRMED REVISION UPDATE 19 AUGUST 2015: UPDATING HIP SIDE AS RIGHT HIP, RESURFACING SYSTEM. PATIENT DATE OF BIRTH TAKEN FROM INJURIES BOARD LETTER. (PD (B)(4)2015) 24 AUG 2015 - RCVD (B)(6) SPREADSHEET - ALSO CONF THE KID NUMBER IS FOR THIS COM. ADDED DP AND KID NUMBER TO COM. - (B)(4) . 3 OCT 2015: REC'D CLAIMSUITE AND SCF WITH FOLLOWING INFO - PRODUCT DETAILS (LOT NUMBERS), REASON FOR REVISION - HIGH METAL IONS AND PAIN, REVISION DATE (B)(6)2015. RECREATED MEDDEV WITH PRODUCTS. SM (B)(6)2015 27 OCT 2015 - REVISION DATE CONF AS TAKEN PLACE ON (B)(6)2015. 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.

    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 (B)(6) 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. WWCAPA (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. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    UPDATE 19 AUGUST 2015: UPDATING HIP SIDE AS RIGHT HIP, RESURFACING SYSTEM. ADDED PATIENT DATE OF BIRTH. TAKEN FROM INJURIES BOARD LETTER (PD 19 AUGUST 2015). 24 AUG 2015 - RCVD KENNEDYS SPREADSHEET - ALSO CONF THE KID NUMBER IS FOR THIS COM. ADDED DP AND KID NUMBER TO COM.

    Description of Event or Problem · 1

    UPDATE 3 OCT 2015: REC'D CLAIMSUITE AND SCF WITH FOLLOWING INFO - PRODUCT DETAILS (LOT NUMBERS), REASON FOR REVISION - HIGH METAL IONS AND PAIN, REVISION DATE 6 OCT 2015. SM

    Description of Event or Problem · 1

    27 OCT 2015 - UPDATE - REVISION DATE CONF AS TAKEN PLACE ON (B)(6) 2015.

    Description of Event or Problem · 1

    NEW LEGAL CLAIM RECEIVED FROM KENNEDY'S. UNKNOWN SYSTEM. UNKNOWN SIDE. PRODUCT DETAILS UNAVAILABLE. NO CONFIRMED REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533448 DEPUY ASR XL FEM IMP SIZE 46 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2872816

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention