BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 3935020 · Received July 15, 2014

    Report

    Report Number
    1818910-2014-23410
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    July 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. 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

    DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FOUND OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS FOR THE PINNACLE MTL INS (B)(4) (METAL LINER), AND ARTICULEZE M HEAD 36MM +5 (METAL HEAD). A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODE 2474822 DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. PER WI-3430 A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE HEAD AND LINER IS NO LONGER REQUIRED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED COMPLAINTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY 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 RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ MAUDE EVENT REPORT (B)(4) STATES: "I'VE BEEN ON CRUTCHES DAILY FOLLOWING THE IMPLANT OF JOHNSON/JOHNSON-DEPUY TOTAL HIP REPLACEMENT. SINCE THE CHONDROITIN, I'VE BEEN TAKEN DAILY FOR 35 YEARS HAD DISCONTINUED WORKING, I ELECTED TO HAVE THE RIGHT HIP REPLACEMENT DONE. NEVER, NEVER, SHOULD HAVE GONE WITH THE DEPUY DEVICE, FOR I WOULD STILL BE WALKING, DRIVING AND CARING FOR MY NEEDS. NOW DEPENDENT ON OTHERS FOR EVERYTHING, AND AM NOT ABLE TO LEAVE THE SECURITY OF MY HOME. TAKING A NARCOTIC (TRAMADOL), AROUND THE CLOCK. NEVERTHELESS, PAIN, AND NOW THE LOSS OF WRISTS AND SHOULDERS' MOVEMENT, AS WELL AS THE OPPOSITE LEG ARE BEGINNING TO HURT AND MALFUNCTION. UPDATE REC'D (B)(6) 2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. LITIGATION ALSO ALLEGES A POPPING/SNAPPING SENSATION IN THE HIP JOINT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412744 PINNACLE SECTOR II CUP 52MM HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US C4AGM1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other