BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE Ø 36MM

    MDR report key: 12826686 · Received November 17, 2021

    Report

    Report Number
    3008021110-2021-00087
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 16, 2021
    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 · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2020298, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 20 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 17 OUT OF 20 GLENOSPHERES WITH LOT #2020298 - STER. 2000344 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. 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 REVISION SURGERY. THE X-RAYS - DATED (B)(6) 2021 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENT: "THE RADIOGRAPHS LOOK OKAY, BUT YOU CAN NEVER REALLY BE SURE ABOUT HUMERUS TORSION AND GLENOID VERSION ON THESE PROJECTIONS. INSTABILITY IS ONE MAJOR SOURCE OF COMPLICATION AFTER RSA, SOFT TISSUE TENSION, STATUS OF REMAINING ROTATOR CUFF, STATUS OF DELTOID MUSCLE ARE VERY IMPORTANT, BUT INVISIBLE ON RADIOGRAPHS. I CANNOT SEE ANY IMPLANT RELATED FAILURE HERE". ACCORDING TO THE PERFORMED ANALYSIS, AND CONSIDERING THAT: CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOTS #2020298; ACCORDING TO THE MEDICAL EXPERT, NO IMPLANT RELATED FAILURE IS VISIBLE ON THE RADIOGRAPHS; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS 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 COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT THE PATIENT NOTICED PAIN ONE DAY AFTER ROLLING OVER (IN BED OR SIMILAR). ACCORDING TO THE COMPLAINT SOURCE, THIS MIGHT HAVE CAUSED THE ISSUE, HOWEVER IT WAS NOT CLEAR IF THIS JUST OCCURRED AROUND THE SAME TIME THE DISLOCATION OCCURRED. THE FOLLOWING COMPONENTS WERE REMOVED: SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #2020298 - STER. 2000344). SMR REVERSE LINER + 6 MM (PRODUCT CODE 1360.50.020, LOT #18AT1SU - STER. 1800311) - PRODUCT NOT SOLD IN THE US. SMR SMALL-R CONNECTOR +4 (PRODUCT CODE 1374.15.314, LOT #2103112 - STER. 2103112). A NEW 44MM GLENOSPHERE WAS IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A MALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731132 SMR GLENOSPHERE Ø 36MM GLENOSPHERE DIA. 36 MM KWS LIMACORPORATE S.P.A. 1374.09.111 2020298

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention