BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 55

    MDR report key: 3103211 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-05763
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    May 5, 2011
    Report Date
    April 25, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA-(B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT.

    Description of Event or Problem · 1

    ASR REVISION; LEFT; RESURFACING; REASON FOR REVISION: UNKNOWN.

    Description of Event or Problem · 1

    CLAIMSUITE ALERT RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND MALALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203573 TOTAL ASR FEM IMP SIZE 55 ASR TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL LTD - 8010379 2130207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention