BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 36 +1.5

    MDR report key: 2963860 · Received February 15, 2013

    Report

    Report Number
    1818910-2013-12469
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES DG4F21, 3008594, D3KEW1, AND D76K51. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2946134 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION. PFS AND MEDICAL RECORDS RECEIVED.

    Description of Event or Problem · 1

    PPF ALLEGES INFECTION AS WELL AS LOOSENING OF CUP ANG STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69034 ASPHERE M SPEC 12/14 36 +1.5 FEMORAL HEAD KWA DEPUY INTL., LTD. 2946134

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other