BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECCENTRICAL GLENOSPHERE DIA. 40 MM

    MDR report key: 16003946 · Received December 19, 2022

    Report

    Report Number
    3008021110-2022-00135
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    October 6, 2022
    Report Date
    September 13, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    MBF
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOTS, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, WE CAN ENSURE THAT ALL THE PRODUCTS PLACED ON THE MARKET WITH THESE LOTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOTS, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, WE CAN ENSURE THAT ALL THE PRODUCTS PLACED ON THE MARKET WITH THESE LOTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. FURTHER INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE BUT NONE WAS AVAILABLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. IN CONCLUSION: - THE CHECK OF THE DHR HIGHLIGHTS NO PRE-EXISTING ANOMALIES ON THE COMPONENTS INVOLVED; - ACCORDING TO THE INFORMATION RECEIVED, PATIENT PRESENTED WITH INFECTION, CAUSED BY C-ACNE. FOR THESE REASONS, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO INFECTION IS 0.078% FOR PRIMA STEM #4, PRODUCT CODE 1357.14.XXX PROTHESIS THIS IS THE FIRST COMPLAINT FOR INFECTION INVOLVING THIS COMPONENT MARKETED FROM 2022. NO SPECIFIC CORRECTIVE ACTION IS NEEDED FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUES.

    Description of Event or Problem · 0

    REVISION SURGERY OF PRIMA HUMERAL SYSTEM PERFORMED ON (B)(6) 2022 DUE TO INFECTION. EXPLANTED COMPONENTS: · PRIMA STEM #4, PRODUCT CODE: 1357.14.034, LOT: 2200584, STER. 2200054. · PRIMA REV. INSERT #SHORT D.40MM, PRODUCT CODE: 1367.15.010, LOT: 2200832, STER. 2200062. · PRIMA REV. INSERT #SHORT D.40MM, PRODUCT CODE: 1367.54.200, LOT: 2124968, STER. 2200071. · SMR CONNECTOR SMALL R, PRODUCT CODE: 1374.15.305, LOT: 2208437, STER. 2200119. · SMR GLENOID PEG TT SMALL-R #M, PRODUCT CODE: 1375.14.652, LOT: 2204905, STER. 2200097. · SMR ECCENT. GLENOSPHERE Ø 40MM, PRODUCT CODE: 1376.09.041, LOT: 2203272, STER. 2200079. ACCORDING TO THE INFORMATION RECEIVED, PATIENT PRESENTED WITH INFECTION, CAUSED BY C-ACNE, ON DATE UNKNOWN. PRIMA IMPLANTS ORIGINALLY IMPLANTED ON (B)(6) 2022 WERE REMOVED AND SO WAS SMR ECCENT. GLENOSPHERE Ø 40MM. EVENT HAPPENED IN US.

    Description of Event or Problem · 0

    REVISION SURGERY OF PRIMA HUMERAL SYSTEM PERFORMED ON 06 OCTOBER 2022 DUE TO INFECTION. EXPLANTED COMPONENTS: · PRIMA STEM #4, PRODUCT CODE 1357.14.034, LOT 2200584, STER. 2200054; · PRIMA REV.INSERT #SHORT D.40MM, PRODUCT CODE 1367.15.010, LOT 2200832, STER. 2200062; · PRIMA REV.INSERT #SHORT D.40MM, PRODUCT CODE 1367.54.200, LOT 2124968, STER. 2200071; · SMR CONNECTOR SMALL R, PRODUCT CODE 1374.15.305, LOT 2208437, STER. 2200119; · SMR GLENOID PEG TT SMALL-R #M, PRODUCT CODE 1375.14.652, LOT 2204905, STER. 2200097; · SMR ECCENT. GLENOSPHERE Ø 40MM, PRODUCT CODE 1376.09.041, LOT 2203272, STER. 2200079. ACCORDING TO THE INFORMATION RECEIVED, PATIENT PRESENTED WITH INFECTION, CAUSED BY C-ACNE, ON DATE UNKNOWN. PRIMA IMPLANTS ORIGINALLY IMPLANTED ON 19TH AUGUST 2022 WERE REMOVED AND SO WAS SMR ECCENT. GLENOSPHERE Ø 40MM. PATIENT -MALE. DATE OF BIRTH - (B)(6) 1936. EVENT HAPPENED IN US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152619 ECCENTRICAL GLENOSPHERE DIA. 40 MM ECCENTRICAL GLENOSPHERE DIA. 40 MM MBF LIMACORPORATE S.P.A 1376.09.041 2203272
    2680938 ECCENTRICAL GLENOSPHERE DIA. 40 MM ECCENTRICAL GLENOSPHERE DIA. 40 MM MBF LIMACORPORATE S.P.A 1376.09.041 2203272

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention