BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 2153099 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-05276
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 12, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1790-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE U.S. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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).

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. 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

    SURGICAL INTERVENTION DUE TO ASR RECALL.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR. CLAIMSUITE REF: (B)(4). ASR XL ACETABULAR SYSTEM (RIGHT); REASON(S) FOR REVISION: NOISE. COMMENTS RECEIVED FROM (B)(6) 11TH AUG 2011 - "THE OPERATION I HAVE REPORTED AS THE FIRST REVISION (DATE (B)(6) 2010) IS TECHNICALLY NOT A REVISION. THE IMPLANT WERE NOT REPLACED (B)(6) 2010. THE SECOND OPERATION (DATE (B)(6) 2011), THE TECHNICALLY REVISION WERE THE IMPLANT IS REPLACED." UPDATE RECEIVED: 12TH MAY 2014 - ADDED FURTHER REASON(S) FOR REVISION: PAIN AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL, LTD. NA 2445350

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention