BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 47

    MDR report key: 2141441 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-11235
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    March 3, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PT WAS REVISED TO ADDRESS PAIN, LOOSENING, NOISE, AND ALVAL.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION BI-LATERAL. ASR HIP RESURFACING SYSTEM (RIGHT); ASR HIP RESURFACING SYSTEM (LEFT). REASONS FOR REVISION FOR BOTH SIDES: COMPONENT LOOSENING, PAIN, NOISE, ALVAL. UPDATE RECEIVED: 20TH FEBRUARY 2014 - MARKED AS LEGAL, ADDED SURGEON: (B)(6) AND ADDED (B)(6) REFERENCE NUMBER. UPDATE RECEIVED: 3RD MARCH 2014 - ADDED WHICH COMPONENT BECAME LOOSE FOR EACH SIDE. BOTH LEFT AND RIGHT SIDE THE CUP BECAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL, LTD. NA 2558688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention