BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE Ø 40MM

    MDR report key: 13010710 · Received December 15, 2021

    Report

    Report Number
    3008021110-2021-00100
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    March 16, 2020
    Report Date
    December 10, 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 #1921503, 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 #1921503 - STER. 1900463 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. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE REQUESTED TO THE COMPLAINT SOURCE, BUT THEY WERE NOT AVAILABLE. BASED ON THE FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1921503, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE 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 PROTHESIS PERFORMED ON (B)(6) 2020, DUE TO IMPLANT DISLOCATION. ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT COMPLAINED OF SOME MILD PAIN ON HIS FIRST POST-OPERATIVE VISIT THAT TOOK PLACE ON (B)(6) 2020, AND X-RAYS SHOWED THAT THE PROSTHESIS HAD DISLOCATED. THE REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2020. THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: SMR GLENOSPHERE Ø 40MM (PRODUCT CODE 1374.09.121, LOT #1921503 - STER. 1900463). SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.15.010, LOT #1920875 - STER. 2000003). SMR REVERSE LINER STD D.40MM (PRODUCT CODE 1365.50.810, LOT #19AT2B8 - STER. 1900424). SMR SMALL-R CONNECTOR +2 (PRODUCT CODE 1374.15.312, LOT #1919130 - STER. 1900405). IT WAS REPORTED THAT THE CAUSE OF THE DISLOCATION WAS NOT KNOWN. PATIENT'S HISTORY OF REVISION SURGERIES IS THE FOLLOWING: SMR REVERSE PROSTHESIS IMPLANTED ON (B)(6) 2020; FIRST REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO IMPLANT DISLOCATION (EVENT REPORTED ON THIS FORM); SECOND REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO IMPLANT DISLOCATION. THE EVENT WAS REGISTERED AS COMPLAINT (B)(6) AND REPORTED TO THE FDA BY MFR #3008021110-2021-00101; THIRD REVISION SURGERY PERFORMED ON (B)(6) 2020, DUE TO INFECTION. A CEMENT SPACER WAS IMPLANTED. THE EVENT WAS REGISTERED AS COMPLAINT (B)(4) AND REPORTED TO THE FDA BY MFR #3008021110-2021-00102. IT WAS FURTHER REPORTED THAT THE CEMENT SPACER ALSO DISLOCATED POST (B)(6) SURGERY. A CUSTOMIZED SHOULDER IMPLANT WAS REQUESTED. PATIENT IS A MALE, (B)(6). IT WAS REPORTED HE HAS TYPE 2 DIABETES. HE SUFFERS OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), HYPERCHOLESTEREMIA AND HYPERTENSION. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911841 SMR GLENOSPHERE Ø 40MM GLENOSPHERE DIA. 40 MM KWS LIMACORPORATE S.P.A. 1374.09.121 1921503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other