BEUDAMED
    FDA Adverse Event Death Summary report: N

    PINNACLE MULTIHOLE II CUP 60MM

    MDR report key: 7689601 · Received July 16, 2018

    Report

    Report Number
    1818910-2018-64452
    Event Type
    Death
    Date Received
    July 16, 2018
    Date of Event
    April 6, 2016
    Report Date
    June 20, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    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

    (B)(4). 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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

    UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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

    COMPLAINT DESCRIPTION: PATIENT EMAIL: (B)(6) IS MY HUSBAND AND HE RECEIVED A DEPUY PROSTHESIS ON (B)(6) 2007 AT (B)(6) MEDICAL CENTER. SINCE LAST YEAR HE HAS SUFFERED GREAT PAIN AND INABILITY TO WALK AND HAS BEEN CONFINED TO BED DUE TO A HUGE GROWTH ON HIS RIGHT THIGH FROM METAL FROM THE PROSTHESIS. THIS REQUIRED THREE HOSPITALIZATIONS, TWO BIOPSIES AND ONE SURGERY TO REMOVE THE GROWTH AND IMPLANT A TEMPORARY PROSTHESIS. NOW HE NEEDS A PERMANENT PROSTHESIS IMMEDIATELY WHICH IS MADE ESPECIALLY FOR HIM BECAUSE THE GROWTH ATE PART OF HIS PELVIC BONE AND THIGH MUSCLE. HIS SUFFERING AND MINE HAVE BEEN GREAT. WE ARE ASKING FOR (B)(6) TO SETTLE OUT OF COURT AND (B)(6) IN COURT AND AN IMMEDIATE PAYMENT TO COVER THE COST OF THE PROSTHESIS. PLEASE, RESPOND IMMEDIATELY AND REMEMBER THE SUFFERING IS INTENSE. AFTER LOOSENING OF PROSTHESIS HIS WIFE ASKS US FOR COMPENSATION. UPDATE (B)(6) 20 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE THE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES RESPIRATORY FAILURE, PAIN, SLEEPING AND WALKING DIFFICULTY, FRICTION AND WEAR BETWEEN CHROMIUM AND COBALT METAL LINER AND HEAD, TOXIC METAL IONS IN BLOOD, TISSUE, BONE AND ELEVATED METAL IONS, RESULTING DISCOMFORT, HIPS WEAK, SWELLING, TENSE FORMATION, WEIGHT LOSS, LOSS OF MOBILITY, LOSS RANGE OF MOTION, INJURY AND MENTAL ANGUISH. ON (B)(6) 2015 SURGEON PERFORMED SURGERY TO RELIEVE PAIN AND DISCOMFORT, FOUND TO HAVE A TUMOR HAD FORMED AND TOOK IT FOR BIOPSY. ON (B)(6) 2015 SECOND BIOPSY DONE. ON (B)(6) 2016 EXPLANTED PINNACLE AND HAVE IT REPLACED TEMPORARY PROSTHESIS IMPLANT. ON (B)(6) 2016 ANOTHER TEMPORARY PROSTHESIS WAS IMPLANTED, PERMANENT NOT DONE DUE TO A SERIOUS INFECTION. ON (B)(6) 2016 PERMANENT REPLACEMENT WAS TO BE IMPLANTED, HOWEVER, PLAINTIFF CONDITION DETERIORATED, NECESSITATING HOSPICE CARE. ON (B)(6) 2016 PATIENT DIED DUE TO ACUTE CARDIOVASCULAR AND RESPIRATORY INSUFFICIENCY AS A DIRECT RESULT OF COMPLICATIONS FROM MULTIPLE SURGERIES. ADDED LAW FIRM NAME, LAWYER NAME. UPDATED DOR AND PATIENT HARM OF THE IP'S. DOI: (B)(6) 2007; DOR: (B)(6) 2016; RIGHT HIP.

    Description of Event or Problem · 1

    UPDATE AD 11 SEP 2018: CORRECTED PATIENT CODE FOR SWELLING AND METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534028 PINNACLE MULTIHOLE II CUP 60MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS KWA DEPUY ORTHOPAEDICS, INC. ZP8DA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R