BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL STEM TRIAL, 14MM

    MDR report key: 6982709 · Received October 27, 2017

    Report

    Report Number
    1651501-2017-00040
    Event Type
    Injury
    Date Received
    October 27, 2017
    Report Date
    October 19, 2017
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 9, 2017. RESULTS: DHR REVIEW; THE MANUFACTURING RECORDS FOR PRODUCT ID TRL-0920-025-14 COULD NOT BE REVIEWED DUE TO THE LOT NUMBER NOT PROVIDED BY THE COMPLAINANT FOR THE REPORTED INCIDENT ALLEGED. COMPLAINTS HISTORY; A REVIEW OF COMPLAINT RECORDS DURING THE LAST 5 YEARS FOUND 16 HUMERAL STEM TRIAL COMPLAINTS REPORTED FOR BREAKAGE. DURING THAT PERIOD OF TIME, THERE HAVE BEEN APPROXIMATELY 3529 TSS SURGERIES REPORTED. THIS REPRESENTS A COMPLAINT RATE OF 0.45% (16/3529) AS SOME OF THE REPORTED EVENTS WERE ASSOCIATED WITH A SERIOUS SEVERITY LEVEL, THIS INDICATES AN ADVERSE TREND. CONCLUSION: AT THIS TIME, THE ROOT CAUSES FOR THIS INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE 1 OF 2 REPORTS: SAME PATIENT, SAME PROCEDURE, DIFFERENT PRODUCTS. OTHER MFG REPORT #:1651501-2017-00041. IT WAS REPORTED THAT DURING THE PREPARATION OF THE HUMERAL CANAL FOR A REVERSE SHOULDER ARTHROPLASTY, THE HUMERAL STEM TRIAL BROKE OFF THE STEM TRIAL HANDLE. THIS CASE WAS A REVISION OF A PRIMARY FROM THE PREVIOUS WEEK THAT HAD DISLOCATED. THE IMPLANTED STEM WAS A SIZE 13, BUT THE SURGEON SIZED UP TO A 14 FOR THE REVERSE TO INCREASE THE BODY HEIGHT. THE SURGEON HAD TO MAKE ANOSTEOTOMY TO BE ABLE TO REMOVE THE IMPACTED STEM TRIAL. THE EVENT LEAD TO 90 MINUTES SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762483 HUMERAL STEM TRIAL, 14MM TITAN TOTAL SHOULDER INSTRUMENTS HWT ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention