BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID PEG TT SMALL-R #XL

    MDR report key: 9394934 · Received December 2, 2019

    Report

    Report Number
    3008021110-2019-00137
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    October 9, 2019
    Report Date
    May 14, 2020
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. NO OTHER COMPLAINTS RECEIVED ON ATOTAL OF 59 ITEMS MANUFACTURED WITH THE SAME LOT (1907801). LIMACORPORATE RECEIVED SOME IMAGES REFERRING TO PATIENT'S BONE STRUCTURES (NO EXACT DATE, NO PROSTHESI IMPLANTED). NO ADDITIONAL INFO RECEIVED BY COMPLAINT SOURCE, NO X-RAYS AVAILABLE, NO EXPLANTS AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. BASED ON THE VERY FEW INFO RECEIVED ON THIS CASE, IT IS POSSIBLE ONLY TO SAY THAT IMPLANT LOOSENING LEADING TO CONVERSION FROM SMR REVERSE PROSTHESIS TO SMR HEMI PROSTHESIS WAS RELATED TO GLENOID BONE FRACTURE EXPERIENCED BY THE PATIENT (NOT KNOW IF ANY TRAUMA WAS EXPERIENCED). ACCORDING TO THE CHECK OF THE MANUFACTURING RECORDS, THIS CASE CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: WE ARE AWARE OF A TOTAL OF 5 CASES - INCLUDING THIS COMPLAINT - OF GLENOID BONE FRACTURE CAUSING SUBSEQUENT IMPLANT LOOSENING AND NECESSITY OF SMR REVERSE PROSTHESIS REVISION SURGERY ON A TOTAL OF MORE THAN 94100 SMR REVERSE IMPLANTS PERFORMED WW. SPECIFIC REVISION RATE IS VERY LOW: 0.005%.

    Description of Event or Problem · 0

    SMR REVERSE PROSTHESIS CONVERTED TO SMR HEMI PROSTHESIS WITH CTA HUMERAL HEAD DUE TO IMPLANT LOOSENING CAUSED BY GLENOID BONE FRACTURE ON (B)(6) 2019. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. DURING THE REVISION SURGERY, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR GLENOID PEG TT SMALL-R #XL PRODUCT CODE 1375.14.654, LOT #1907801 STER. 1900200. SMR GLENOID BASEPLATE SMALL-R PRODUCT CODE 1375.15.605, LOT #1911327 STER. 1900293. NO FURTHER INFORMATION AVAILABLE. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT#S INVOLVED, NO ANOMALY WAS DETECTED ON THE COMPONENTS PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON (B)(6) 2019 DUE TO IMPLANT LOOSENING CAUSED BY GLENOID FRACTURE. SMR REVERSE WAS CONVERTED INTO CTA. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. DURING REVISION, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR GLENOID PEG TT SMALL-R #XL, CODE 1375.14.654, LOT #1907801, STER. 1900200. SMR GLENOID BASEPLATE SMALL-R, CODE 1375.15.605, LOT #1911327, STER. 1900293. NO FURTHER INFORMATION AVAILABLE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190587 SMR GLENOID PEG TT SMALL-R #XL SMR GLENOID PEG TT SMALL-R #XL KWS LIMACORPORATE SPA 1375.14.654 1907801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention