BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE MTL INS NEUT36IDX54OD

    MDR report key: 2896947 · Received January 4, 2013

    Report

    Report Number
    1818910-2013-10283
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 5, 2013
    Report Date
    November 5, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    ADDITIONAL INFO CATALOG AND LOT NUMBER. UPDATE: (B)(4) 2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. NO OTHER REPORTS WERE FOUND AGAINST THE FEMORAL STEMS. 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 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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. 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. 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

    UPDATE REC'D 3/28/2016: LITIGATION RECEIVED. AN UNKNOWN STEM IS BEING ADDED TO FOR EACH HIM FOR THE ALLEGED HIGH METAL ION LEVELS. THIS COMPLAINT WAS UPDATED ON: 4/12/2016.

    Description of Event or Problem · 1

    UPDATE 5/4/2016 - DISC 324 PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. PFS REPORTED NICKEL ALLERGY WITH HIVES, ANXIETY, MENTAL DISTRESS, UNABLE TO WALK AND HAD TO BUY MOTORIZED SCOOTER, COULD SEE FLECKS OF METAL COMING THROUGH SKIN AROUND HIP, UNABLE TO HIKE/WALK ANY DISTANCE/GARDEN/OR CAMP. RIGHT HIP REVISION SURGICAL REPORT NOTED NO OVERT EVIDENCE OF METALLOSIS LIKE LEFT HIP AND THE FEMORAL HEAD AND LINER HAD SCORING TO THEM WHEN REVISED. LEFT HIP REVISION SURGICAL REPORT NOTED METALLOSIS, EXTENSIVE AMOUNT OF BLOODY SYNOVIAL FLUID, EXTENSIVE GRAYISH SYNOVIAL MATERIAL AND DIFFICULTY REMOVING LINER. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: MAY 26, 2016.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, POPPING/SNAPPING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4599 PINNACLE MTL INS NEUT36IDX54OD TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS, INC. 1818910 1125622

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other