BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 48

    MDR report key: 4801989 · Received May 28, 2015

    Report

    Report Number
    1818910-2015-22025
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD.8010379
    Product Code
    KWA
    PMA / PMN Number
    PK073413
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. (B)(4).

    Description of Event or Problem · 1

    UPDATE REC'D 1/25/2016: LITIGATION RECEIVED. LITIGATION ALLEGES PAINFUL AND DANGEROUS COMPLICATIONS AND HAVING TO HAVE A PAINFUL REVISION OPERATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 1/28/2016.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347232 ASR 300 SPIKED CUP SIZE 48 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD.8010379 2719094

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention