BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 60MM

    MDR report key: 7544501 · Received May 25, 2018

    Report

    Report Number
    1818910-2018-60564
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    October 15, 2012
    Report Date
    April 25, 2018
    Manufacturer
    . DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    KWA
    UDI-DI
    10603295009863
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED DEBILITATING PAIN, DISCOMFORT, AND SORENESS IN THE AREA OF HIP IMPLANT, AFFECTING PATIENT'S ABILITY TO WALK, SIT, AND/OR STAND. ADDITIONALLY, METAL IONS AND PARTICLES HAVE BEEN RELEASED INTO PATIENT'S BLOOD, TISSUE AND BONE SURROUNDING THE IMPLANT. PATIENT WILL LIKELY NEED TO UNDERGO PREMATURE REVISION SURGERY. DOI: (B)(6) 2009 - DOR: NONE REPORTED (RIGHT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE - 11/13/2012 - THE COMPLAINT HAS BEEN REOPENED BECAUSE THE SALES REP HAS REPORTED THAT THE PATIENT WAS REVISED. ON (B)(6) 2012 DUE TO PAIN, IT WAS ALSO NOTED THAT THE PATIENT HAS HISTORY OF PREVIOUS ACETABULAR/PELVIC FRACTURE (PLATES & SCREW FIXATION). UPDATE 12/3/2012 - ADDITIONAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW. UPDATE AD 25 APR 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF RECORDS. PPF ALLEGES BONE FRACTURE. THE LAW FIRM NAME, EXPIRATION, UDI AND PATIENT HARM WERE UPDATED AS WELL. CUP WAS ADDED DUE TO PREVIOUS ALLEGED ACETABULAR FRACTURE. (PART 121722060: KWA/ K073504 ). DOI: (B)(6) 2009; DOR: (B)(6) 2012; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387633 PINNACLE SECTOR II CUP 60MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS KWA . DEPUY ORTHOPAEDIC INC, 1818910 D13CV1000 10603295009863

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention