BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 54MM

    MDR report key: 9234156 · Received October 24, 2019

    Report

    Report Number
    1818910-2019-111820
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    August 10, 2015
    Report Date
    April 21, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295009832
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT 1818910-2019-117267 - 1 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

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). 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 RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, AND ELEVATED METAL ION LEVELS. UPDATE AD 9 OCT 2018. (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND IMPLANTS RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION. CUP HAS BEEN ADDED TO THE COMPLAINT. PRODUCT AND LOT NUMBERS UPDATED. ADDED LAW FIRM, REVISION HOSPITAL, AND SURGEON. CORRECTED DOR. UPDATED PATIENT INITIALS. DOI: (B)(6) 2009; DOR: (B)(6) 2014; RIGHT HIP. ACTUAL SURGERY DATE WAS NOT SPECIFIED, SINCE NO OPERATIVE NOTES PROVIDED TO VERIFY ACTUAL DATE, THE REPORTED DATE ON PPF IS BEING USED AND WILL BE UPDATED ONCE ADDITIONAL INFORMATION IS RECEIVED. THE PATIENT HAS BILATERAL HIP IMPLANT, PLEASE SEE (B)(4) FOR THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029745 PINNACLE SECTOR II CUP 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US D13CF1000 10603295009832

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R