BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 58MM

    MDR report key: 3052252 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-15222
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    November 11, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. REASON FOR REVISION HAS NOT BEEN PROVIDED AND NO FURTHER DETAILS REGARDING THE EVENT HAVE BEEN MADE AVAILABLE TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDED: (EXPIRATION DATE) INFORMATION RECEIVED FROM (B)(6). CONFIRMED REVISION OF PINNACLE IMPLANTS. REASON NOT PROVIDED, REVISION DATE CONFIRMED. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    CONFIRMED REVISION OF PINNACLE IMPLANTS. REASON NOT PROVIDED, REVISION DATE CONFIRMED.

    Description of Event or Problem · 1

    (B)(6) 2013 - UPDATE: PRODUCT CODES RECEIVED AND UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156672 PINNACLE SECTOR II CUP 58MM HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1818910 Y5PDV1000

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention