BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.S. GLENOID M CEMENTED

    MDR report key: 5059688 · Received September 7, 2015

    Report

    Report Number
    9613350-2015-01071
    Event Type
    Injury
    Date Received
    September 7, 2015
    Date of Event
    October 30, 2013
    Report Date
    August 24, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW: DHR RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. TREND ANALYSIS: NO TREND IDENTIFIED. COMPATIBILITY CHECK: THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER GMBH. DEVICE ANALYSIS. THE DEVICE ANALYSIS WAS NOT PERFORMED AS THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. REVIEW OF EVENT DESCRIPTION: ON (B)(6) 2013 (6 WEEKS AFTER IMPLANTATION) MMI RADIOGRAPHIC FINDINGS INDICATE SEVERAL GLENOHUMERAL SUBLUXATIONS. ON (B)(6) 2014 (6 MONTHS AFTER IMPLANTATION) MMI RADIOGRAPHIC FINDINGS INDICATE 1MM GLENOID RADIOLUCENCY AND MODERATE GLENOHUMERAL SUBLUXATIONS ON (B)(6) 2014 (12 MONTHS AFTER IMPLANTATION) MMI RADIOGRAPHIC FINDINGS INDICATE AN INCREASE IN GLENOID RADIOLUCENCY FROM 1MM TO 3MM. REVIEW OF X-RAYS: X-RAYS WERE AVAILABLE FOR INVESTIGATION. THREE PREOPERATIVE X-RAYS, 3 X-RAYS OF 6TH POSTOP. WEEK, 3 X-RAYS 6TH POSTOP. MONTH, AND 3 X-RAYS OF 12TH POSTOP. MONTH. ON ALL X-RAYS THE CORRECT POSITIONING OF THE ANATOMICAL SHOULDER GLENOID CAN BE OBSERVED. THE POSITIONING OF THE SIDUS HEAD AND ANCHOR SEEM SO BE ANATOMICALLY CORRECT. ON THE AP X-RAYS AT 6 WEEKS AND LATER FOLLOW-UPS A LITTLE RADIOLUCENCY AREA IS VISIBLE AROUND THE CEMENTED PEGS OF THE GLENOID COMPONENT. ON THE AXILLARY X-RAYS OF 6 MONTH A GLENOHUMERAL SUBLUXATION CAN BE OBSERVED. REVIEW OF SURGICAL NOTES: THE SURGICAL REPORT DATED (B)(6) 2013 WAS RETURNED FOR EVALUATION. THE SURGICAL NOTES DO DESCRIBE THE DEVIATIONS FROM THE SURGICAL TECHNIQUE. THE NOTES OF THE FOLLOW-UP VISIT DATED (B)(6) 2013, (B)(6) 2014 WERE ALSO RETURNED. THE VISITS REPORTED GOOD OUTCOME AND NO MAJOR CONCERNS. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA: ASEPTIC LOOSENING/LOOSENING DUE TO WRONG RADII COMBINATION, NORMAL USE, OVERLOAD, WRONG POSITIONING DUE TO WRONG GEOMETRY OF PEG, WRONG POSITIONING, INSUFFICIENT BONE. POSSIBLE AS THE X-RAYS SHOWED SUBOPTIMAL POSITIONING OF THE IMPLANTS. THE SIZE OF THE IMPLANTS SEEMED TO MATCH THE ANATOMY OF THE PATIENT. ADVERSE BODY REACTION DUE TO MATERIAL NOT BIOCOMPATIBLE, DUE TO BIOINCOMPATIBLE DUE TO HARMFUL LEACHABLES FROM IMPLANT MATERIAL AND LOOSENING / ALLERGIC REACTION DUE TO CORROSION OF PARTICULATE METAL, DUE TO FRETTING, LEADS TO ADVERSE BODY REACTION. NOT POSSIBLE AS BIOCOMPATIBILITY SPECIFICATION AND MATERIAL COMPATIBILITY SPECIFICATION CERTIFY THE BIOCOMPATIBILITY OF THE MATERIAL. ADDITIONALLY, THE DOCUMENTS OF MATERIAL OF THE SPECIFIC LOT INDICATE THAT THERE WAS NO MATERIAL FAULT. IMPLANT BREAKAGE, LOSS OF FUNCTION, PAIN DUE TO AGING OF IMPLANT MATERIALS RESULTS IN REDUCED MATERIAL STRENGTH OR CAPACITY TO PERFORM INTENDED FUNCTION. POSSIBLE AS THE X-RAYS SHOWED SOME RADIOLUCENCY BETWEEN THE CEMENT AND THE BONE. IT IS POSSIBLE THAT THE BONE CEMENT HAS REDUCED MATERIAL STRENGTH OR DO NOT PERFORM THE INTENDED FUNCTION. SURGERY FAILURE DUE TO INSUFFICIENT, UNAVAILABLE OR OVER COMPLICATED SURGICAL TECHNIQUE OR DUE TO MISSING OR UNCLEAR INFORMATION REGARDING CROSS COMPATIBILITY BETWEEN EXISTING ZIMMER SYSTEMS AND SIZES. NOT POSSIBLE AS SURGICAL TECHNIQUES CONTAIN ALL INFORMATION. DAMAGE TO BONE THROUGH INTRAOPERATIVE CORRECTIONS AFFECT PERFORMANCE IN-VIVO DUE TO INTRAOPERATIVE CORRECTIONS MIGHT CONTRIBUTE TO POOR LONG-TERM RESULTS. NOT POSSIBLE AS NO INTRAOPERATIVE CORRECTIONS WERE REPORTED IN THE SURGICAL NOTES. SUBLUXATION DUE TO INCOMPATIBLE GLENO-HUMERAL CURVATURE DUE TO FAILURE OF HUMERAL HEAD-GLENOID INTERFACE. POSSIBLE AS THE XRAYS SHOWED GLENOHUMERAL SUBLUXATION. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT THE PATIENT WAS IMPLANTED AN A.S. GLENOID M CEMENTED ON THE RIGHT SIDE ON (B)(6) 2013. ON (B)(6) 2013 MMI RADIOGRAPHIC FINDINGS INDICATE SEVERAL GLENOHUMERAL SUBLUXATIONS. ON (B)(6) 2014 MMI RADIOGRAPHIC FINDINGS INDICATE 1MM GLENOID RADIOLUCENCY AND MODERATE GLENOHUMERAL SUBLUXATIONS. ON (B)(6) 2014 MMI RADIOGRAPHIC FINDINGS INDICATE AN INCREASE IN GLENOID RADIOLUCENCY FROM 1MM TO 3MM. CURRENTLY, THE PATIENT IS BEING MONITORED DUE TO RADIOLUCENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591048 A.S. GLENOID M CEMENTED ANATOMICA GLENOID COMPONENT KWS ZIMMER GMBH NA 2685059

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other