BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DRILL

    MDR report key: 9328475 · Received November 15, 2019

    Report

    Report Number
    1818910-2019-115859
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    May 14, 2016
    Report Date
    October 25, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. 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).

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿FEASIBILITY OF DAY-CASE TOTAL HIP ARTHROPLASTY: A SINGLE-CENTRE OBSERVATIONAL STUDY¿ BY JENS ROLIGHED LARSEN, ET AL, PUBLISHED BY HIP INTERNATIONAL (2017), VOL. 27, NO. 1, PP. 60-65, DOI: 10.5301/HIPINT.5000421, WAS REVIEWED. THE AUTHORS EVALUATED THE FEASIBILITY, EFFICACY, SAFETY AND PATIENT SATISFACTION OF SAME-DAY (<12 HOURS) THA OPERATION AND DISCHARGE. 29 CONSECUTIVE PATIENTS WERE SCREENED AND 20 PARTICIPATED BETWEEN OCTOBER 2014 AND JANUARY 2015. DEPUY IMPLANTS USED: ALL PATIENTS WERE IMPLANTED WITH A DEPUY PINNACLE CUP AND LINER PAIRED WITH A CORAIL STEM AND DEPUY FEMORAL HEAD. RESULTS: THERE WERE NO REPORTS OF AMI, DVT, INSUFFICIENT ANALGESIA, OR CIRCULATORY INSTABILITY. THERE WERE NO REPORTED REOPERATIONS OR REVISION SURGERIES REPORTED. THERE WERE NO INSTANCES OF INFECTION, JOINT DISLOCATION OR READMISSIONS AT 6-WEEK FOLLOW UP. THERE WAS 1 REPORTED INTRAOPERATIVE COMPLICATION: AN INITIATOR DRILL BROKE AND BECAME EMBEDDED IN THE FEMORAL BONE AND A WIRE CERCLAGE NEEDED TO BE INSERTED. NO CABLING WAS REQUIRED. THERE WERE NO LONG-TERM CONSEQUENCES AND THE PATIENT HAD NO POSTOPERATIVE COMPLICATIONS. THERE WAS 1 REPORTED CASE OF A MAJOR BLEED GREATER THAN 400 ML. TREATMENT WAS UNKNOWN. 1 PATIENT HAD POSTOPERATIVE NAUSEA AND RECEIVED ANTIEMETIC MEDICATION IN PACU. THE PATIENT HAD NO LONG-TERM CONSEQUENCES AND WAS COMPLICATION FREE AT 6-WEEK FOLLOW-UP. CAPTURED IN THIS COMPLAINT: PINNACLE CUP AND LINER, CORAIL STEM, FEMORAL HEAD, AND UNKNOWN HIP INSTRUMENT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124657 UNK DRILL UNK DRILL HTW DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention