BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9189300 · Received October 14, 2019

    Report

    Report Number
    1818910-2019-109342
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    January 1, 2013
    Report Date
    September 26, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "DETECTING CAUSE OF DISLOCATION AFTER TOTAL HIP ARTHROPLASTY BY PATIENT-SPECIFIC FOUR-DIMENSIONAL MOTION ANALYSIS" WRITTEN BY HIDENOBU MIKI, NOBUHIKO SUGANO, KAZUO YONENOBU, KOSUKE TSUDA, MAKI HATTORI, AND NAOKI SUZUKI PUBLISHED BY CLINICAL BIOMECHANICS 28 (2013) 182¿186 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE'S PURPOSE WAS TO STUDY THE REASONINGS OF DISLOCATION UTILIZING MOTION ANALYSIS AFTER THA. IT IS NOTED ONE CASE UTILIZED DEPUY PRODUCTS: (B)(6) YEAR OLD FEMALE WITH ZTT CUP AND S-ROM STEM. IT IS REASONABLE TO CONCLUDE THE FEMORAL HEAD WAS ALSO A DEPUY PRODUCT ALTHOUGH NOT SPECIFIED. THE PATIENT EXPERIENCED 3 DISLOCATIONS POST OP AND UNDER WENT REVISION. NO FURTHER DETAILS PROVIDED REGARDING WHAT PRODUCTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978204 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention