BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HUMERAL HEAD

    MDR report key: 7235373 · Received February 2, 2018

    Report

    Report Number
    0001825034-2018-00435
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    July 27, 2017
    Report Date
    March 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN THE (B)(6). REPORT SOURCE, LITERATURE - VERSTRAELEN, F.U. ET AL (2017). CLINICAL AND RADIOLOGICAL RESULTS 7 YEARS AFTER COPELAND SHOULDER RESURFACING ARTHROPLASTY IN PATIENTS WITH PRIMARY GLENOHUMERAL OSTEOARTHRITIS: AN INDEPENDENT MULTICENTRE RETROSPECTIVE STUDY. EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, 28(1), 15-22. DOI: 10.1007/S00590-017-2023-8. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT GLENOID EROSION WAS APPARENT IN ELEVEN SHOULDERS BUT TO A MINIMAL EXTENT. AT THE FINAL FOLLOW-UP, AN INCREASE IN GLENOID EROSION WAS OBSERVED IN FIFTEEN SHOULDERS. FOUR OF THESE PATIENTS DID NOT HAVE ANY SIGNS OF GLENOID EROSION PRE-OPERATIVELY. ONE PATIENT SHOWED SEVERE GLENOID EROSION AFTER 7.5 YEAR. THIS PATIENT ALSO SHOWED A SIGNIFICANT SUPERIOR GLENOHUMERAL SUBLUXATION AND HAD AN IMPAIRED SHOULDER FUNCTION WITH A CMS OF 27.0 AND AN AGE- AND GENDER-ADJUSTED CMS OF 38.5 THE OTHER THREE PATIENTS HAD SIGNS OF MILD GLENOID EROSION AND DID NOT HAVE AN IMPAIRED FUNCTIONAL OUTCOME. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT GLENOID EROSION WAS OBSERVED IN 13 OUT OF 15 SHOULDER PATIENTS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80482 UNKNOWN HUMERAL HEAD PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other