BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 52MM

    MDR report key: 1053581 · Received May 22, 2008

    Report

    Report Number
    1818910-2008-01966
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K001534
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE PERFORMED INVESTIGATION, PRODUCT CONTRIBUTION WAS NOT IDENTIFIED AND A NEED FOR CORRECTIVE ACTION IS NOT INDICATED, HOWEVER, TESTING IS ONGOING TO FURTHER INVESTIGATE POSSIBLE CAUSES OF DISASSOCIATION AND TO DETERMINE IF FUTURE ACTION IS APPROPRIATE. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS DISASSOCIATION OF THE CUP AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 100 ACET CUP 52MM 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA AE2GJ1000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention