BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE GLENOID, CAGE PEGGED, ALPHA

    MDR report key: 6416685 · Received March 20, 2017

    Report

    Report Number
    1038671-2017-00175
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    February 28, 2017
    Report Date
    May 20, 2019
    Manufacturer
    EXACTECH, INC
    Product Code
    KWS
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REVISION OF THE GLENOID COMPONENT REPORTED IN EXPERIENCE C2017-123 WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND BONE, WHICH LED TO THE ASEPTIC (NON-INFECTED) GLENOID LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND ADEQUATE INFORMATION WAS NOT PROVIDED. THE FREQUENCY OF OCCURRENCE RANKING SCALE IS VERY LOW; THEREFORE, THIS DOES NOT APPEAR TO BE DESIGN-RELATED. EXACTECH IS NOT AWARE OF RECEIVING ANY OTHER COMPLAINT REPORTS INVOLVING PARTS FROM THE FOLLOWING MANUFACTURING LOTS. LOT 4103640 OF QUANTITY 6, 2015, LOT 4693992 OF QUANTITY 40, 2016, LOT 4658377 OF QUANTITY 50, 2016, LOT 3898549 OF QUANTITY 36, 2015. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THE NAMED DEVICES WERE ACCEPTED WITH CONFORMANCE TO THE DEVICE REQUIREMENTS. THEREFORE, THIS DOES NOT APPEAR TO BE MANUFACTURING-RELATED. IN A REVIEW OF THE LABELING ALL PATIENTS SHOULD BE INSTRUCTED ON THE LIMITATIONS OF THE PROSTHESIS AND THE POSSIBILITY OF SUBSEQUENT SURGERY. THE PATIENT SHOULD BE CAUTIONED TO MONITOR ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES AND FOLLOW THE WRITTEN INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. IT IS A KNOWN COMPLICATION THAT EXCESSIVE ACTIVITY AND TRAUMA AFFECTING JOINT REPLACEMENTS HAVE BEEN ASSOCIATED WITH PREMATURE FAILURE. DEVICE SPECIFIC RISK- FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROSTHESIS OR ANY OF ITS COMPONENTS, MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. IT IS A KNOWN COMPLICATION THAT A PATIENT'S AGE, WEIGHT, OR ACTIVITY LEVEL WOULD CAUSE THE SURGEON TO EXPECT EARLY FAILURE OF THE SYSTEM. ALSO, AS PART OF THE PRE-OPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR THE POSTOPERATIVE PERIOD. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. IN THE INVESTIGATION OF THIS COMPLAINT ADDITIONAL INFORMATION HAS BEEN REQUESTED ABOUT PATIENT AND EVENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 61 YO FEMALE PATIENT EXPERIENCED A SHOULDER REVISION SURGERY DUE TO GLENOID LOOSENING. A NEW GLENOID WAS PLACED. THE INITIAL SURGERY WAS (B)(6) 2015. THE PATIENT WAS STABLE LEAVING THE OR AND HAD NOT REPORTED ANY ISSUES TO THE SURGEON. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2015. REVISION DUE TO LOOSE GLENOID COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200951 EQUINOXE GLENOID, CAGE PEGGED, ALPHA GLENOID KWS EXACTECH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention