BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 3161379 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18575
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 20, 2013
    Report Date
    March 9, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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

    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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODE AK3DJ1000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES AL7EB1, 2174095, 2027861, 2248975 AND 2249925 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. 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 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 CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. -LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED PAIN, SWELLING, LACK OF MOBILITY, DAMAGE TO SURROUNDING TISSUE AND BONE CAUSED BY INFLAMMATION, METALLOSIS, PSEUDOTUMORS, BURSITIS, AND BONE EROSION. DOI: (B)(6) 2006 - DOR: NONE REPORTED (UNKNOWN SIDE). DOI: (B)(6) 2006 - DOR: NONE REPORTED (UNKNOWN SIDE). PATIENT IS A RESIDENT OF (B)(6) . UPDATE: (B)(6) 2012 - MEDICAL RECORDS WERE RECEIVED. PART/LOT INFORMATION WAS IDENTIFIED WITH INVOICE SEARCH. RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW. DOI: (B)(6)2006 (LEFT HIP). DOI: (B)(6) 2006 - DOR: (B)(6) 2012 (RIGHT HIP). UPDATE: (B)(6) 2013 - THE COMPLAINT HAS BEEN UPDATED BECAUSE IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2013, TO ADDRESS GROIN PAIN, VERTICAL MALPOSITIONING OF THE CUP, AND MILD DISCOLORATION OF THE JOINT FLUID. THE STEM WAS ALSO IN 60 DEGREES OF ANTEVERSION, BUT WAS NOT REMOVED.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE FOR THE RIGHT HIP INDICATED PAIN. THE REVISION OPERATIVE NOTE FOR THE LEFT HIP INDICATED PAIN, METALLOSIS, CORROSION ON THE STEM/HEAD, AND HIGH METAL IONS. LAB RESULTS FROM (B)(6) 2011 INDICATED THE METAL IONS LEVELS WERE BELOW 7PPB. THE LEFT HIP REVISION OPERATIVE NOTE INDICATED SOFT TISSUE IMPINGEMENT AND THE CUP WAS ACTUALLY AT 20 DEGREES ANTEVERSION, SO IT WAS NOT MALPOSITIONED AS PREVIOUSLY STATED. DURING THE LEFT HIP REVISION, THEY TRIED TO REMOVE AN ACETABULAR SCREW AND THE SCREWDRIVER BROKE AND LEFT IN THE PATIENT. AT THIS TIME, THE MANUFACTURER OF THE SCREWDRIVER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263051 PINNACLE SECTOR II CUP 52MM ACETABULAR CUP LPH DEPUY ORTHOPAEDICS INC US AL7EB1000

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention