BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 6344089 · Received February 20, 2017

    Report

    Report Number
    1818910-2017-13009
    Event Type
    Injury
    Date Received
    February 20, 2017
    Date of Event
    January 13, 2017
    Report Date
    January 29, 2017
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 DUE (B)(4) 2017. ASR XL LEFT. REASON(S) FOR REVISION: PAIN, NOISEUPDATE - ALERT DATE (B)(4) 2017. (B)(4) CONFIRMED REVISION SURGERY TOOK PLACE ON (B)(4) 2017. AMENDED EVENT DATE AND ADDED DATE OF REVISION - SEE ATTACHMENT DATED (B)(4) 2017. EK (B)(4) 2017. UPDATE ALERT DATE 25 JAN 2017. ADDED LOT NUMBER, MANUFACTURING DATE AND FACLITY FOR CUP AND HEAD - LOT NUMBERS UNAVAILABLE FOR STEM AND SLEEVE UPDATE AUG 15, 2017: EMAIL NOTIFICATION FROM (B)(4) RECEIVED. THERE IS NO NEW INFORMATION ADDED. THIS COMPLAINT WAS UPDATED ON: AUG 18, 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

    REASON(S) FOR REVISION: PAIN, NOISE. UPDATE - ALERT DATE (B)(6) 2017. (B)(6) CONFIRMED REVISION SURGERY TOOK PLACE ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125404 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2524567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention