BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 50

    MDR report key: 2950400 · Received February 8, 2013

    Report

    Report Number
    1818910-2013-00707
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    March 26, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK073413
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    ADDITIONAL NARRATIVE: 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

    LEGAL CLAIM RECEIVED.

    Description of Event or Problem · 1

    UPDATE REC'D 03/26/2014 - MEDICAL RECORDS RECEIVED. MEDICAL RECORDS INDICATE CUP MALPOSITIONING. PART/LOT INFORMATION PROVIDED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THE COMPLAINT WAS UPDATED ON: 04/23/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54355 ASR 300 SPIKED CUP SIZE 50 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2775050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other