BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 52

    MDR report key: 3031366 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-03488
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    October 28, 2013
    Report Date
    February 26, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK073413
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, DISCOMFORT AND EXCESSIVE METAL DEBRIS AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: 02/26/2014 - PPD RECEIVED. INVOICE RETRIEVED AND PART/LOT INFORMATION UPDATED. DOR PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THIS INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 03/26/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134147 ASR 300 SPIKED CUP SIZE 52 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2733796

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other