BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9143426 · Received October 1, 2019

    Report

    Report Number
    1818910-2019-106904
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    February 13, 2013
    Report Date
    September 11, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    PRODUCT COMPLAINT # (B)(4). (B)(4) USED TO CAPTURE SURGICAL INTERVENTION.  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

    THE LITERATURE ARTICLE ENTITLED, "A MINIMALLY INVASIVE APPROACH FOR TOTAL HIP ARTHROPLASTY DOES NOT DIMINISH EARLY POST-OPERATIVE OUTCOME IN OBESE PATIENTS: A PROSPECTIVE, RANDOMISED TRIAL" WRITTEN BY THOMAS DIENSTKNECHT, CHRISTIAN LÜRING, MARKUS TINGART, JOACHIM GRIFKA, AND ERNST SENDTNER PUBLISHED BY INTERNATIONAL ORTHOPAEDICS (SICOT) (2013) 37:1013¿1018 DOI 10.1007/S00264-013-1833-5 ON 28 FEBRUARY 2013 WAS REVIEWED FOR MDR REPORTABILITY. THE ARTICLE REPORTS ONE REVISION FOR LOOSENING OF THE CUP IN A GROUP IDENTIFIED TO HAVE DEPUY PINNACLE CUPS, FOUR UNDISPLACED FRACTURES OF THE PROXIMAL FEMUR IDENTIFIED TO HAVE DEPUY CORAIL STEMS OCCURRED DURING SURGERY AND WERE TREATED WITH CERCLAGES. AND TWO CASES OF DEEP VEIN THROMBOSIS WERE DIAGNOSED WITHOUT ANY THERAPEUTIC RELEVANCE DURING THE RECOVERY PERIOD. ADVERSE EVENTS: CUP LOOSENING, INTRAOPERATIVE FRACTURES (INTERVENTIONS PROVIDED), DVT. IMPACTED PRODUCTS: DEPUY CUP, DEPUY CORAIL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934490 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention