BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9354015 · Received November 21, 2019

    Report

    Report Number
    1818910-2019-115774
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    August 5, 2017
    Report Date
    October 30, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. (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

    "LITERATURE ARTICLE ENTITLED, ¿OVERESTIMATION OF THE RISK OF REVISION WITH KAPLAN-MEIER PRESENTING THE LONG-TERM OUTCOME OF TOTAL HIP REPLACEMENT IN OLDER PATIENTS¿ BY KALLIOPI LAMPROPOULOU-ADAMIDOU, ET AL, PUBLISHED BY HIP INTERNATIONAL (2017), DOI: 10.5301/HIPINT.5000575, WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO REVIEW THE LONG-TERM OUTCOME OF CEMENTED CHARNLEY THAS 20-42 YEARS AGO IN PATIENTS OLDER THAN 60 YEARS. THE ARTICLE REVIEWS OUTCOMES FOR CHARNLEY IMPLANTS BETWEEN THE YEARS 1973-1995. IT IS UNKNOWN HOW MANY ADVERSE EVENTS AND PATIENT HARMS ARE ATTRIBUTED TO CHARNLEY IMPLANTS AFTER THEY BECAME DEPUY PRODUCTS IN 1990. THE EVENTS THAT ARE IDENTIFIED AS BEING IMPLANTED BEFORE 1990 ARE EXCLUDED FROM THIS COMPLAINT. THIS PAPER IS A FOLLOW-UP (B)(4). THE EVENTS PREVIOUSLY REPORTED IN (B)(4) ARE NOT INCLUDED IN THIS COMPLAINT. IMPLANTED DEPUY PRODUCTS; CEMENTED CHARNLEY CUP AND STEM WITH AN UNKNOWN FEMORAL HEAD. THE CEMENT USED WAS MANUFACTURED BY A COMPETITOR. RESULTS NOT PREVIOUSLY REPORTED: 7 REVISIONS FOR INFECTION. 3 DEATHS RESULTING FROM POSTOPERATIVE THROMBOEMBOLISM. 9 CUP REVISIONS DUE TO ASEPTIC LOOSENING. THERE IS INSUFFICIENT INFORMATION WITHIN THE TEXT OF THE ARTICLE TO ATTRIBUTE THE LOOSENING TO THE CUP THAT WAS CEMENTED WITH COMPETITOR CEMENT. CAPTURED IN THIS COMPLAINT: CHARNLEY CUP, STEM, AND HEAD: NO REPORTED PRODUCT PROBLEM. PATIENT HARMS: INFECTION, MEDICAL DEVICE REMOVAL, THROMBOEMBOLISM, SURGICAL INTERVENTION. CHARNLEY CUP, HEAD, AND STEM FOR DEATH. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151495 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention