BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ8 HI OFF

    MDR report key: 8817601 · Received July 23, 2019

    Report

    Report Number
    1818910-2019-99071
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 25, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    UDI-DI
    10603295060093
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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). 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

    CLINICAL NOTIFICATION RECEIVED FOR LEFT TOTAL HIP REVISION TO ADDRESS ADVERSE LOCAL TISSUE REACTION: ADVERSE REACTION TO METAL DEBRIS. DOI: (B)(6) 2004; DOR: (B)(6) 2019, (LEFT HIP). PRODUCTS PRESENT AT THE TIME OF THE REVISION: CATALOG: 121722062, LOT: WD3JB1005, DEVICE: PINNACLE SHELL SECTOR 62MM; CATALOG: 121887362, LOT: 1143245, DEVICE: ULTAMET LINER METAL 36MM X 62MM; CATALOG: 136553000, LOT: 1804726, DEVICE: ARTICUL/EZE HEAD METAL 36MM +8.5; CATALOG: 157011150, LOT: YR3C91000, DEVICE: SUMMIT STEM POROCOAT HIGH OFFSET SZ 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613446 SUMMIT POR TAPER SZ8 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS, INC. 1818910 YR3C91000 10603295060093

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention