BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HUMERAL STEM

    MDR report key: 4704268 · Received April 17, 2015

    Report

    Report Number
    2520274-2015-13030
    Event Type
    Injury
    Date Received
    April 17, 2015
    Date of Event
    May 29, 2014
    Report Date
    April 8, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    MBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN (PROSTHESIS/UNKNOWN QUANTITY/UNKNOWN LOT. ADDITIONAL CODES: HSD, KWT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORTS IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: ANDRE´S-CANO, P; ET AL (2015) RESULTS OF UNCEMENTED HEMIARTHROPLASTY AS PRIMARY TREATMENT OF SEVERE PROXIMAL HUMERUS FRACTURES IN THE ELDERLY. EUR J ORTHOP SURG TRAUMATOL 25, 273¿280. THE PURPOSE OF THIS STUDY WAS TO ANALYZE FUNCTIONAL AND RADIOLOGIC RESULTS OF A CONSECUTIVE SERIES OF ELDERLY PATIENTS WHO UNDERWENT UNCEMENTED HEMIARTHROPLASTY AS PRIMARY TREATMENT OF COMPLEX PROXIMAL HUMERAL FRACTURES. BETWEEN 2009 AND 2010, 21 CONSECUTIVE PATIENTS WITH SEVERE PROXIMAL HUMERUS FRACTURE AND AN INDICATION FOR SURGERY (FRACTURES WITH THREE OR FOUR FRAGMENTS, HEAD-SPLITTING AFFECTING MORE THAN 40% OF THE ARTICULAR SURFACE, AND SOME FRACTURE DISLOCATIONS) WERE TREATED BY PERFORMING AN UNCEMENTED HEMIARTHROPLASTY WITH THE EPOCA SHOULDER ARTHROPLASTY SYSTEM (SYNTHES, (B)(4), USA). AT THE END OF THE FOLLOW-UP, TEN PATIENTS HAD NO SYMPTOMS IN THE AFFECTED SHOULDER, WHEREAS SEVEN HAD SLIGHT OCCASIONAL PAIN, BUT DID NOT REQUIRE ANALGESICS. FOUR PATIENTS HAD MORE FREQUENT AND SEVERE PAIN. THE RADIOGRAPH CLEARLY SHOWED CONSOLIDATION OF THE TUBEROSITIES IN 15 CASES, NON-UNION IN ONE AND REABSORPTION IN FIVE. THIS IS 12 OF 12 FOR (B)(4). THIS REPORT REFERS TO AN UNKNOWN EPOCA SHOULDER ARTHROPLASTY FOR ONE (1) UNKNOWN PATIENT WHO EXPERIENCED A SERIOUS INJURY NONUNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258052 COCR HUMERAL STEM MBF SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention