BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID PEG TT SMALL-R #M

    MDR report key: 15189870 · Received August 9, 2022

    Report

    Report Number
    3008021110-2022-00067
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    July 2, 2022
    Report Date
    November 8, 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

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE TT PEGS THAT WERE RELEASED WITH LOT NUMBER 2202842, STER. 2200084. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE TT PEGS THAT WERE RELEASED WITH LOT NUMBER LOT 2202842 STER. 2200084. PRODUCT WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. NO COMPLAINTS RECEIVED ON A TOTAL OF 63 GLENOID TT PEGS MANUFACTURED WITH THE SAME LOT#. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-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. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR GLENOID PEG TT SMALL-R #M, COMMERCIAL CODE 1375.14.XXX FOR BONE FRACTURE IS 0.031%. 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 BONE FRACTURE OCCURRED ON (B)(6) 2022, DURING SMR REVERSE SURGERY. ACCORDING THE INFORMATION RECEIVED, THE CAUSE OF THE FRACTURE WAS ATTRIBUTED TO THE SIZE OF THE PEG (PRODUCT CODE 1375.14.652, LOT 2202842, STER. 2200084), TOO LARGE FOR THE PATIENT, WHICH WAS DESCRIBED AS SMALL, WITH DEFICIENT GLENOID. DUE TO THE INTRA-OPERATIVE BONE FRACTURE, HEMI PROSTHESIS WAS IMPLANTED WITH A REVERSE ADAPTER AND IT WAS REPORTED THAT THE PATIENT WILL NEED TO BE REVISED IN THE FUTURE. PATIENT DATA: FEMALE, BORN ON (B)(6) 1938. THIS EVENT OCCURRED IN THE UNITED STATES.

    Description of Event or Problem · 0

    INTRA-OPERATIVE BONE FRACTURE OCCURRED ON (B)(6) 2022, DURING SMR REVERSE SURGERY. ACCORDING THE INFORMATION RECEIVED, THE CAUSE OF THE FRACTURE WAS ATTRIBUTED TO THE SIZE OF THE PEG (PRODUCT CODE 1375.14.652 LOT 2202842 STER. 2200084), TOO LARGE FOR THE PATIENT, WHICH WAS DESCRIBED AS SMALL, WITH DEFICIENT GLENOID. DUE TO THE INTRA-OPERATIVE BONE FRACTURE, HEMI PROSTHESIS WAS IMPLANTED WITH A REVERSE ADAPTER AND IT WAS REPORTED THAT THE PATIENT WILL NEED TO BE REVISED IN THE FUTURE. PATIENT DATA: FEMALE, BORN ON (B)(6). THIS EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989114 SMR GLENOID PEG TT SMALL-R #M SMR TT METAL BACK PEG (TI6AL4V) - S-R MEDIUM KWS LIMACORPORATE S.P.A 1375.14.652 2202842

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Hospitalization| S