BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE FRACTURE STEM

    MDR report key: 4397294 · Received January 8, 2015

    Report

    Report Number
    0001825034-2015-00064
    Event Type
    Injury
    Date Received
    January 8, 2015
    Report Date
    December 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT DETAILS AND PRODUCT IDENTIFICATION WERE NOT PROVIDED FOR THIS PATIENT. THE ARTICLE WAS WRITTEN BY NASIR SHAH, HAFIZ J. IQBAL, STEVEN BROOKES-FAZAKERLEY & CHRIS SINOPIDIS IN INTERNATIONAL ORTHOPAEDICS (SICOT) (2011) 35:861¿867 DOI 10.1007/S00264-010-1083-8 THE MANUFACTURER REPORT NUMBER OF THE MEDWATCH WHICH CONTAINS THE ABOVE REFERENCED JOURNAL ARTICLE IS 1825034-2015-00071. IT IS LIKELY THAT THE COMPLICATION FOR THIS PATIENT HAS ALREADY BEEN REPORTED; HOWEVER, IT CANNOT BE DETERMINED BASED ON THE LIMITED PATIENT INFORMATION MADE AVAILABLE IN THE ARTICLE. SHOULD ADDITIONAL INFORMATION RELATING TO THE PATIENT COMPLICATION BE RECEIVED, THE UPDATED INFORMATION WILL BE FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "SHOULDER HEMI-ARTHROPLASTY FOR THE TREATMENT OF THREE AND FOUR PART FRACTURES OF THE PROXIMAL HUMERUS USING COMPREHENSIVE FRACTURE STEM" WHICH AIMED TO EXAMINE THE FUNCTIONAL OUTCOME AND THE RADIOLOGICAL RESULTS OF PROXIMAL HUMERAL HEMI-ARTHROPLASTY FOR FRACTURES USING THE COMPREHENSIVE FRACTURE SYSTEM, MANUFACTURED BY BIOMET; AND TO INVESTIGATE THE INFLUENCE OF DIFFERENT PARAMETERS INCLUDING AGE, GENDER, CUFF DEFICIENCY AND SUPER MIGRATION ON THE RESULTS AND OUTCOME. A PATIENT WAS IDENTIFIED IN THE ARTICLE WHO UNDERWENT HEMI-ARTHROPLASTY ON AN UNKNOWN DATE. PATIENT FOLLOW-UP RESULTS PROVIDED AT MONTH THIRTY-FOUR (34) POST-IMPLANTATION INDICATES RADIOGRAPHIC EVIDENCE OF SUBLUXATION OF THE IMPLANT. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18647 UNKNOWN COMPREHENSIVE FRACTURE STEM PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention