BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 3072878 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15758
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    October 4, 2011
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    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

    (B)(4)

    Additional Manufacturer Narrative · 1

    UDI: UNAVAILABLE. SEE SECTION D FOR ANY PRODUCT INFORMATION RECEIVED. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED OTHER REPORTS AGAINST THE FEMORAL HEAD AND LINER. PER PROCEDURE, THESE DEVICE'S ARE EXEMPT FROM DEVICE HISTORY RECORD REVIEW. A SEARCH OF THE COMPLAINTS DATABASES WAS NOT POSSIBLE AGAINST THE UNKNOWN STEM PRODUCT/LOT CODE COMBINATION. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY STILL 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.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM WPC (B)(4). REASON FOR ORIGINAL COMPLAINT: PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS. DOI (B)(6) 2007 - DOR (B)(6) 2011 (RIGHT HIP). **UPDATE: (B)(6) 2013 -LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THE CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS AND/OR LOOSENED FROM THE PATIENT'S ACETABULUM. IT IS FURTHER ALLEGES ELEVATED METAL LEVELS AND SQUEAKING AND THUMPING IN THE HIP. AN UNKNOWN CUP HAS BEEN ADDED AND REPORTED TO ADDRESS LOOSENING.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM (B)(4). REASON FOR ORIGINAL COMPLAINT: PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS. DOI (B)(6) 2007 - DOR (B)(6) 2011 (RIGHT HIP). UPDATE: 3/28/13 -LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES THE CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS AND/OR LOOSENED FROM THE PATIENT'S ACETABULUM. IT IS FURTHER ALLEGES ELEVATED METAL LEVELS AND SQUEAKING AND THUMPING IN THE HIP. AN UNKNOWN CUP HAS BEEN ADDED AND REPORTED TO ADDRESS LOOSENING. UPDATE REC'D 11/10/2015 - THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT ALSO HAD METALLOSIS. THERE WAS METAL DEBRIS THROUGHOUT THE CAPSULE. AT THIS TIME THE PATIENT'S FEMORAL STEM IS BEING REPORTED FOR THE ELEVATED METAL ION LEVELS. THE COMPLAINT WAS UPDATED ON: 12/03/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174509 PINNACLE SECTOR II CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS KWA DEPUY ORTHOPAEDICS INC US BK8HY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention