BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE Ø 36MM

    MDR report key: 12007732 · Received June 16, 2021

    Report

    Report Number
    3008021110-2021-00046
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    June 2, 2021
    Report Date
    November 2, 2021
    Product Code
    KWS
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2012449, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) GLENOSPHERES WITH LOT #2012449 - STER. 2000266 HAVE BEEN IMPLANTED. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #18AT0HW - STER. 1800237, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) REVERSE LINERS WITH LOT #18AT0HW - STER. 1800237 HAVE BEEN IMPLANTED. THE EXPLANTED ITEMS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OP PREVIOUS SURGERY. THE X-RAYS RECEIVED - DATED 26/05/2021 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. ACCORDING TO THE MEDICAL CONSULTANT, THE IMAGES SHOW A PERIPROSTHETIC FRACTURE AND A LOOSE AND SUPERIORLY MIGRATED CUSTOM-MADE GLENOID PROSTHESIS. DOWNSIZING THE 36 MM GLENOSPHERE WAS A SUB-OPTIMAL STRATEGY FOR DEALING WITH INSTABILITY. CONSIDERATION SHOULD BE GIVEN TO IMPLANTING A HEMIARTHROPLASTY. CONSIDERING THAT: - CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #18AT0HW AND LOT #2012449; - ACCORDING TO THE MEDICAL CONSULTANT, A SUB-OPTIMAL STRATEGY WAS CHOSEN FOR DEALING WITH THE INSTABILITY; - PATIENT HAS HAD SEVERAL FALLS AND HAS A LONG HISTORY OF REVISION SURGERIES; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO DISLOCATION IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6), 2021, DUE TO DISLOCATION. PATIENT HAS HAD MULTIPLE REVISIONS FOR DISLOCATIONS AND INSTABILITY DUE TO SEVERAL FALLS. ACCORDING TO THE COMPLAINT SOURCE, PATIENT WAS ON THE SURGICAL WARD, PERFORMING DAILY ACTIVITIES WHEN HER SHOULDER DISLOCATED. IT WAS REPORTED THAT PATIENT COULD NOT RECALL WHICH MOVEMENT RESULTED IN DISLOCATION. ALL THE HUMERAL COMPONENTS WERE REMOVED: · SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #2012449 - STER. 2000266). · SMR REVERSE LINER RETENTIVE +6 MM (PRODUCT CODE 1361.50.020, LOT #18AT0HW - STER. 1800237) - PRODUCT NOT SOLD IN THE US. · SMR CEMENTLESS MINI STEM (PRODUCT CODE 1304.15.130, LOT #2003900 - STER. 2000152). · SMR HUMERAL EXTENSION + 9 MM (PRODUCT CODE 1352.15.001, LOT #2013694 - STER. 2000320). · SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #1817981 - STER. 1900015). · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2016691 - STER. 2000295). THE CUSTOM-MADE METAL BACK GLENOID AND TWO SMR CORTICAL BONE SCREWS WERE LEFT IN-SITU. IT WAS REPORTED THAT SURGEON WAS UNCERTAIN WHAT MOVEMENTS AND FORCE PATIENT PERFORMED TO DISLOCATE SHOULDER. RECENTLY, THE PATIENT WAS REVISED ON (B)(6), 2021 DUE IMPLANT DISLOCATION CAUSED BY A FALL (THE EVENT WAS REGISTERED AS COMPLAINT #(B)(4)). THE PATIENT UNDERWENT THE FOLLOWING SURGERIES: - (B)(6), 2018: REMOVAL OF COMPETITOR'S PROSTHESIS - NO SMR IMPLANTS. - (B)(6), 2018: SMR REVERSE PROSTHESIS IMPLANTED. - (B)(6), 2018: OPEN REDUCTION FOR DISLOCATION, NO COMPONENTS REMOVED OR EXCHANGED. - (B)(6), 2018: REVISION DUE TO DISLOCATION CAUSED BY A FALL. PATIENT NOT COMPLIANT (NOT WEARING THE SLING). - (B)(6), 2019: OPEN REDUCTION FOR DISLOCATION, NO COMPONENTS REMOVED OR EXCHANGED. - (B)(6), 2018: REMOVAL OF GLENOID COMPONENTS AND CONVERSION TO HEMIARTHROPLASTY - EVENT REPORTED TO THE TGA AS DIR # (B)(4). - (B)(6), 2019: CONVERSION SURGERY FROM HEMI TO REVERSE. REMOVAL OF HUMERAL COMPONENTS, IMPLANT OF CUSTOM-MADE GLENOID AND NEW HUMERAL COMPONENTS - COMPLAINT REGISTERED AS #(B)(4). - (B)(6), 2021: REVISION DUE TO LOOSENING CAUSED BY MULTIPLE FALLS. HUMERAL COMPONENTS EXCHANGED - REGISTERED AS COMPLAINT #(B)(4). - (B)(6), 2021: REVISION DUE TO DISLOCATION CAUSED BY MULTIPLE FALLS. HUMERAL COMPONENTS EXCHANGED - REGISTERED AS COMPLAINT #(B)(4). - (B)(6), 2021: REVISION DUE TO DISLOCATION CAUSED BY A FALL. DOWNSIZED GLENOSPHERE FROM 44 TO 36MM. REMOVAL OF ONE MB'S SCREWS AS IT WAS LOOSE - REGISTERED AS COMPLAINT #(B)(4). PATIENT IS A FEMALE, 78 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF LOT #18AT0HW AND LOT #2012449, NO ANOMALIES WERE DETECTED ON THE PRODUCTS MANUFACTURED WITH THE SAME LOT #S. THIS IS THE FIRST AND ONLY COMPLAIN RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. PATIENT HAS HAD MULTIPLE REVISIONS FOR DISLOCATIONS AND INSTABILITY DUE TO SEVERAL FALLS. ACCORDING TO THE COMPLAINT SOURCE, PATIENT WAS ON THE SURGICAL WARD, PERFORMING DAILY ACTIVITIES WHEN HER SHOULDER DISLOCATED. IT WAS REPORTED THAT PATIENT COULD NOT RECALL WHICH MOVEMENT RESULTED IN DISLOCATION. ALL THE HUMERAL COMPONENTS WERE REMOVED: SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #2012449 - STER. 2000266). SMR REVERSE LINER RETENTIVE +6 MM (PRODUCT CODE 1361.50.020, LOT #18AT0HW - STER. 1800237) - PRODUCT NOT SOLD IN THE US. SMR CEMENTLESS MINI STEM (PRODUCT CODE 1304.15.130, LOT #2003900 - STER. 2000152). SMR HUMERAL EXTENSION + 9 MM (PRODUCT CODE 1352.15.001, LOT #2013694 - STER. 2000320). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #1817981 - STER. 1900015). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2016691 - STER. 2000295). THE CUSTOM-MADE METAL BACK GLENOID AND TWO SMR CORTICAL BONE SCREWS WERE LEFT IN-SITU. IT WAS REPORTED THAT SURGEON'S UNCERTAIN WHAT MOVEMENTS AND FORCE PATIENT PERFORMS TO DISLOCATE SHOULDER. RECENTLY, THE PATIENT WAS REVISED ON (B)(6) 2021 DUE IMPLANT DISLOCATION CAUSED BY A FALL (THE EVENT WAS REGISTERED AS COMPLAINT # (B)(4)). PATIENT IS A FEMALE, (B)(6) YEARS OLD. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909865 SMR GLENOSPHERE Ø 36MM GLENOSPHERE DIA. 36 MM KWS 1374.09.111 2012449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other