BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID 48MM-STERILE

    MDR report key: 4202817 · Received October 27, 2014

    Report

    Report Number
    2520274-2014-14360
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KWT
    PMA / PMN Number
    PK072578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODES: MBF AND HSD. IMPLANT DATE: (B)(6) 2008. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: NO DEVICE WAS RECEIVED. THE DESIGN AND CLINICAL RISK MANAGEMENT HAS BEEN INVESTIGATED. BASED ON THE PROVIDED INFORMATION AND WITHOUT MATERIAL NO FURTHER EVALUATION IS POSSIBLE, BUT CONSIDERING THE AVAILABLE DATA, THE LISTED IMPLANTS CAN BE CONSIDERED AS SAFE AND EFFICIENT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AN EPOCA GLENOID AND METALBACK WAS REVISED AFTER APPROXIMATELY EIGHT YEARS WITHIN THE PATIENT. REVISION WAS BEING DONE DUE TO ROTATOR CUFF FAILURE AND THE NEED TO IMPLANT A REVERSE PROSTHESIS. UPON EXPOSURE IT WAS DISCOVERED THAT THE ENTIRE SUPERIOR HALF OF THE POLYETHYLENE GLENOID HAD WORN COMPLETELY THROUGH. IN ADDITION, THE SUPERIOR HALF OF THE METALBACK HAD WORN THROUGH, LEAVING ONLY THE PEG REMAINING IN THE SUPERIOR PORTION. DUE TO THIS METAL WEAR, BLACK RESIDUE (UNDERSTOOD TO BE TITANIUM REMNANTS) HAD FILLED THE JOINT SPACE. SURGEON WAS UNAWARE OF THE EXTENT OF IMPLANT WEAR UNTIL THE REVISION OPERATION; THERE WAS A PROLONGATION OF SURGERY BY THIRTY MINUTES. THE EVENT OCCURRED OVER TIME IN SITU FOLLOWING HISTORIC IMPLANTATION. THE PATIENT OUTCOME WAS REPORTED AS EXCELLENT FOLLOWING REVISION TO REVERSE PROSTHESIS; HOWEVER THE SURGEON IS UNSURE OF THE CONSEQUENCES THE METALLOSIS WOULD BRING TO PATIENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684654 GLENOID 48MM-STERILE PROSTHESIS, SHOULDER, NONCONSTRAINED, METAL/POLYMER CEMENTED KWT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention