BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3335514 · Received September 9, 2013

    Report

    Report Number
    1818910-2013-26675
    Event Type
    Injury
    Date Received
    September 9, 2013
    Date of Event
    August 25, 2013
    Report Date
    August 25, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR 2850141 LOT CODE FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE CONDUCTED. NO ADDITIONAL INFORMATION WAS OBTAINED. 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 THE ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS GROIN PAIN. THERE WERE NO SIGNS OF WEAR, DEBRIS, OR DISEASED TISSUE.

    Description of Event or Problem · 1

    PPF AND STICKER SHEET RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES ELEVATED METAL IONS. THE HOSPITAL, LAWYER, AND LAW FIRM HAVE BEEN UPDATED. AN IP FOR THE STEM IS ADDED DUE TO THE ALLEGED ELEVATED METAL IONS. DOI: (B)(6), 2009; DOR: (B)(6) 2018; LEFT HIP

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446371 PINNACLE MTL INS NEUT36IDX50OD ACETABULAR LINER KWA DEPUY INTERNATIONAL LTD. 8010379 2850141

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention