BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +5.0

    MDR report key: 8701255 · Received June 14, 2019

    Report

    Report Number
    1818910-2019-96048
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    October 18, 2017
    Report Date
    May 27, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033660
    PMA / PMN Number
    K071830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE 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. PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION SINCE RELEASE FOR DISTRIBUTION. 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. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. 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). 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

    PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. PINNACLE CLAIM FORM HAS NO ALLEGATION PROVIDED. AFTER REVIEW OF MEDICAL RECORDS ON CERAMIC ON METAL, THE PATIENT WAS REVISED DUE TO METALLOSIS AND TRUNNIONOSIS WITH ELEVATED METAL IONS. INDICATIONS OF THE PROCEDURE STATED, THE PATIENT DEVELOPED SIGNS AND SYMPTOMS AND CLINICAL FINDINGS CONSISTENT WITH METALLOSIS. CLINICAL VISIT ON (B)(6) 2016 REPORTED PAIN, LIMITED RANGE OF MOTION, BURSITIS, WALKS WITH ANTALGIC GAIT, AND METALLOSIS. HOWEVER, RECENT LABORATORY RESULTS ON (B)(6) 2016 SHOWS CR ION LEVEL IS BELOW 7PPB. DOI: (B)(6) 2009 - DOR: (B)(6) 2017 (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494297 DLT TS CER HD 12/14 36MM +5.0 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 2954787 10603295033660

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention