BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF CENT HIP 45X28 GRY

    MDR report key: 8484148 · Received April 4, 2019

    Report

    Report Number
    1818910-2019-89819
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 18, 2019
    Report Date
    March 18, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    UDI-DI
    10603295003359
    PMA / PMN Number
    K812672
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: EXAMINATION OF THE RETURNED DEVICE COMPONENTS IS UNABLE TO CONFIRM THE REPORTED PROBLEM. THE COMPONENTS CAN BE ASSEMBLED AS INTENDED WITH NO EXCESS MOVEMENT. 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. 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

    IT WAS REPORTED THAT THE PLASTIC LINER OF PART 1035-45-000 WAS LOOSE AND WOBBLY UPON CONSTRUCTION. SURGEON PUT IN HAND AND TOOK A LONG LOOK AT IT AND WAS UNCOMFORTABLE IMPLANTING INTO PATIENT. REPLACEMENT PART OF SAME SIZE WAS IMPLANTED INSTEAD. THERE WAS A SURGICAL DELAY OF 5 MINUTES. DOE: (B)(6) 2019. RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276578 SELF CENT HIP 45X28 GRY HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI KWY DEPUY ORTHOPAEDICS INC US HY3221 10603295003359

    Patients

    Seq Age Sex Outcome Treatment
    1