BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 45

    MDR report key: 5542451 · Received April 1, 2016

    Report

    Report Number
    1818910-2016-16559
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    January 25, 2016
    Report Date
    March 17, 2016
    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
    OTHER

    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. (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

    ASR REVISION. ASR XL- RIGHT SIDE. REASON(S) FOR REVISION: PAIN, ALVAL. UPDATE: SEE CRAWFORD'S EMAIL DATED (B)(4) 2016. UPDATED STEM LOT NUMBER. RESUBMIT MEDDEV. (LF (B)(4) 2016). UPDATE (B)(4) 2017: EMAIL NOTIFICATION FROM KENNEDYS RECEIVED. THERE IS NO NEW INFORMATION. THIS COMPLAINT WAS UPDATED ON: (B)(4) 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

    PATIENT UNDERWENT A REVISION TO ADDRESS ALVAL/SOFT TISSUE REACTION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198340 DEPUY ASR XL FEM IMP SIZE 45 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2868811

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention