BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 3081150 · Received April 26, 2013

    Report

    Report Number
    1818910-2013-16148
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    July 11, 2011
    Report Date
    April 3, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    KWA
    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 REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. FURTHER INFORMATION REGARDING THIS REPORT WAS NOT MADE AVAILABLE TO CUSTOMER QUALITY. 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. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM KENNEDY'S. CONFIRMED REVISION OF RIGHT PINNACLE/S-ROM IMPLANTS DUE TO PAIN AND FINDINGS OF HIGH METAL ION LEVELS. DOR - (B)(6) 2011. UPDATE OCT 18, 2017: PINNACLE SPREADSHEET RECEIVED. UPDATED PRODUCT CODE AND LOT NUMBER OF CUP. THIS COMPLAINT WAS UPDATED ON NOV 14, 2017. 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.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM (B)(6). CONFIRMED REVISION OF RIGHT PINNACLE/S-ROM IMPLANTS DUE TO PAIN AND FINDINGS OF HIGH METAL ION LEVELS. DOR - (B)(6) 2011. UPDATE OCT 18, 2017: PINNACLE SPREADSHEET RECEIVED. UPDATED PRODUCT CODE AND LOT NUMBER OF CUP. THIS COMPLAINT WAS UPDATED ON NOV 14, 2017. 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 RIGHT PINNACLE/S-ROM IMPLANTS DUE TO PAIN AND FINDINGS OF HIGH METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183073 UNKNOWN LINER ACETABULAR LINER KWA DEPUY ORTHOPAEDICS, INC.1818910 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention