BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR ECCENT. GLENOSPHERE Ø 36MM

    MDR report key: 9022059 · Received September 13, 2019

    Report

    Report Number
    3008021110-2019-00105
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    August 15, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT MUCH INFO AVAILABLE ON THIS CASE. SPECIFICALLY: NO X-RAYS PROVIDED; NO EXPLANTED COMPONENTS TO BE RETURNED TO THE MANUFACTURER AND FURTHER ANALYZED BY LIMA CORPORATE. BASED ON THE FEW DETAILS AVAILABLE, WE CANNOT PERFORM A DEEPER ANALYSIS OTHER THAT THE DHRS CHECK OF THE TWO COMPONENTS THAT HAVE BEEN EXPLANTED, WHICH CONFIRMED PRODUCTS FULL CONFORMITY TO THE DRAWINGS SPECIFICATIONS: NO DEVIATION DETECTED ON A TOTAL OF 108 SMR REVERSE LINERS + 3 MM CODE 1360.50.015 BELONGING TO LOT# 19AT0TH; NO DEVIATION DETECTED ON A TOTAL OF 40 SMR ECCENT. GLENOSPHERES Ø 36 MM CODE 1376.09.031 BELONGING TO LOT# 1814889; MOREOVER, THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE TWO LOT#. STATING THAT: NO PRE- EXISTING ANOMALIES WERE FOUND ON THE MANUFACTURING CHARTS OF THE INVOLVED COMPONENTS; EXPLANTS WERE NOT RECEIVED AND THEREFORE NOR A VISUAL INSPECTION OF THEIR CONDITIONS NOR A DIMENSIONAL/FUNCTIONAL CHECK WAS POSSIBLE; NO CLINICAL PATIENT DATA RECEIVED OTHER THAN PATIENT IS A (B)(6) MALE WITH A "LOT OF SOFT TISSUE"; ACCORDING TO COMPLAINT SOURCE, ADVERSE EVENT WAS FAVORED BY THE "LEVERING ACTION" OF THE SOFT TISSUE WHEN THE ARM WAS PUT IN ABDUCTION, JUST FEW DAYS AFTER PRIMARY SURGERY; DURING REVISION SURGERY IT WAS IMPLANTED A BIGGER SIZE GLENOSPHERE AND A LATERALIZING LINER, NO X-RAYS WERE AVAILABLE TO BE ANALYZED BY OUR MEDICAL CONSULTANT. NO DEFINITIVE CONCLUSION CAN BE DRAWN ON THE ROOT CAUSE FOR THIS DISLOCATION. HOWEVER, BASED ON THE INFO RECEIVED, WE CAN SPECULATE THAT THE CAUSE FOR DISLOCATION COULD BE MOSTLY RELATED TO PATIENT'S SOFT TISSUE POSSIBLY COMBINED WITH A SUBOPTIMAL CHOICE OF COMPONENTS ORIGINALLY IMPLANTED (A BIGGER SIZE GLENOSPHERE AND A LATERALIZING LINER WAS IMPLANTED DURING THE REVISION SURGERY). AT THIS STAGE, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT-RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, WW SMR REVERSE REVISION RATE DUE TO JOINT DISLOCATION/LUXATION/INSTABILITY IS 0.14%. NO SPECIFIC CORRECTIVE ACTION FOR THIS CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET. NOTE: THIS IS A INITIAL AND FINAL COMBINED MDR AS ALL THE AVAILABLE INFORMATION HAS ALREADY BEEN RECEIVED AND ANALYZED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO DISLOCATION OCCURRED JUST FEW DAYS AFTER PRIMARY SURGERY: PRIMARY SMR REVERSE WAS PERFORMED ON (B)(6) 2019; REVISION SURGERY DUE TO DISLOCATION TOOK PLACE ON (B)(6) 2019. ACCORDING TO THE INFO RECEIVED, PATIENT INVOLVED IS "QUITE A BIG MAN WITH A LOT OF SOFT TISSUE (FAT)". WHEN THE ARM WAS PUT INTO ABDUCTION, THE SOFT TISSUE HELPED TO LEVER THE NEW REPLACEMENT OUT OF JOINT. THIS WAS RECTIFIED BY REPLACING, DURING THE SURGERY OCCURRED ON (B)(6) AUGUST, THE GLENOSPHERE IN SITU WITH A BIGGER SIZE ONE AND THE REVERSE LINER +3 MM PREVIOUSLY IMPLANTED WITH A LATERALIZED ONE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823433 SMR ECCENT. GLENOSPHERE Ø 36MM ECCENTRICAL GLENOSPHERE DIA. 36 MM (KWS, KWT, MBF, PHX) KWS LIMACORPORATE S.P.A. 1376.09.031 1814889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention