BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SMALL-R -MEDIUM GLENOID TT PEG

    MDR report key: 14303154 · Received May 6, 2022

    Report

    Report Number
    3008021110-2022-00031
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    June 4, 2022
    Report Date
    September 28, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 A TOTAL OF 64 GLENOID TT PEGS MANUFACTURED WITH THE SAME LOT#. WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    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 A TOTAL OF 30 GLENOID TT PEGS MANUFACTURED WITH THE SAME LOT#. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS INTRA-OPERATIVE ISSUE, PREOPERATIVE OR POST-OPERATIVE X-RAYS WERE REQUESTED BUT NOT AVAILABLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THE FACTS: CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #, NO PRE-EXISTING ANOMALIES WERE FOUND. DURING THE SURGERY OF A PATIENT WITH SCLEROTIC BONE, DENSE CORTICAL AND SOFT CANCELLOUS BONE, THE GLENOID BONE FRACTURED WHEN REDUCING THE HUMERUS CAUSING THE GLENOSPHERE TO MOVE AND THE BASEPLATE TO LOOSE. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR GLENOID PEG TT, COMMERCIAL CODE 1375.14.XXX FOR BONE FRACTURE 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 ISSUES. NOTE: THIS IS A FINAL MDR

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE EXPERIENCED ON (B)(6) 2022 DURING A SMR REVERSE PROSTHESIS: DURING THE SURGERY OF A PATIENT WITH SCLEROTIC BONE, DENSE CORTICAL AND SOFT CANCELLOUS BONE, THE GLENOID BONE FRACTURED WHEN REDUCING THE HUMERUS CAUSING THE GLENOSPHERE TO MOVE AND THE BASEPLATE TO LOOSE. ACCORDING TO THE COMPLAINT SOURCE, THE SUSPECTED CAUSE OF THE EVENT IS THE SMR SMALL-R -MEDIUM GLENOID TT PEG, PRODUCT CODE 1375.14.652, LOT 2125719, STER. 2200010. A TOTAL OF 30 MINUTES OF PROLONGED SURGERY TIME TO REPAIR THE FRACTURE WITH A BONE GRAFT WAS REPORTED. A CONVERSION TO SMR HEMI PROSTHESIS WAS DONE (NO DETAILED INFO ABOUT PRODUCTS IMPLANTED). EVENT HAPPENED IN THE US.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE EXPERIENCED ON (B)(6) 2022 DURING A SMR REVERSE PROSTHESIS: DURING THE SURGERY OF A PATIENT WITH SCLEROTIC BONE, DENSE CORTICAL AND SOFT CANCELLOUS BONE, THE GLENOID BONE FRACTURED WHEN REDUCING THE HUMERUS CAUSING THE GLENOSPHERE TO MOVE AND THE BASEPLATE TO LOOSE. THE PRODUCT INVOLVED IN THE ISSUE WAS THE FOLLOWING: SMR GLENOID PEG TT SMALL-R #M (PRODUCT CODE 1375.14.652, LOT NUMBER 2125719, STERILIZATION NUMBER 2200010). A TOTAL OF 30 MINUTES OF PROLONGED SURGERY TIME TO REPAIR THE FRACTURE WITH A BONE GRAFT WAS REPORTED. A CONVERSION TO SMR HEMI PROSTHESIS WAS DONE (NO DETAILED INFO ABOUT PRODUCTS IMPLANTED). EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100319 SMR SMALL-R -MEDIUM GLENOID TT PEG SMR SMALL-R -MEDIUM GLENOID TT PEG KWS LIMACORPORATE S.P.A 1375.14.652 2125719

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other