BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 53

    MDR report key: 4615159 · Received March 18, 2015

    Report

    Report Number
    1818910-2015-16536
    Event Type
    Injury
    Date Received
    March 18, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 10, 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. 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. 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. 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 TO TAKE PLACE ON (B)(6) 2015. ASR RESURFACING - RIGHT. REASON FOR REVISION - UNKNOWN. * THE PRODUCT CODE FOR FEMORAL HEAD WAS INCORRECT FOR THE LOT NUMBER - PRODUCT CODE 999804652 CAME UP AS A CUP AND DID NOT HAVE THE LOT NUMBER 1949445 - THE LOT NUMBER ON JDE SHOWED UP FEMORAL HEAD 999804653 - THIS HAS BEEN USED ON THE COM. LOT 1945516 WAS NOT FOR A HEAD BUT CUP - 999805360 - 1945516. ALL CHECKED ON JDE. * ON 23 FEB 2015 - UPDATE AMENDED MANUFACTURE DATE ON FEMORAL HEAD - 01 SEPT 2005 - (B)(6) 2015. UPDATE 10 MAR 2015: REC'D CRAWFORDS CLAIMSUITE WITH REASON FOR REVISION (ALVAL / SOFT TISSUE REACTION), DP REFERENCE, SURGEON (B)(6). (B)(6) 2015. UPDATE ALERT DATE (B)(6) 2016. ATTACHED SCF, ADDED ADDITIONAL HOSPITAL, ADDED ADDITIONAL REASON FOR REVISION . TAKEN FROM SCF DATED (B)(6) 2016. ADDITIONAL REASON FOR REVISION: PAIN. 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 TO TAKE PLACE ON (B)(6) 2015. ASR RESURFACING - RIGHT. REASON FOR REVISION - UNKNOWN. THE PRODUCT CODE FOR FEMORAL HEAD WAS INCORRECT FOR THE LOT NUMBER - PRODUCT CODE (B)(4)CAME UP AS A CUP AND DID NOT HAVE THE LOT NUMBER 1949445 - THE LOT NUMBER ON (B)(6) SHOWED UP FEMORAL HEAD 999804653 - THIS HAS BEEN USED ON THE COM. LOT 1945516 WAS NOT FOR A HEAD BUT CUP - (B)(6). 23 FEB 2015 - UPDATE AMENDED MANUFACTURE DATE ON FEMORAL HEAD - 01 SEPT 2005 - (B)(6). UPDATE 10 MAR 2015: REC'D (B)(6) WITH REASON FOR REVISION (ALVAL / SOFT TISSUE REACTION), DP REFERENCE, SURGEON 1ST NAME ((B)(6)). (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185357 TOTAL ASR FEM IMP SIZE 53 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 1949445

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention