BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE FINNED HUMERAL BODY

    MDR report key: 13449842 · Received February 4, 2022

    Report

    Report Number
    3008021110-2022-00005
    Event Type
    Injury
    Date Received
    February 4, 2022
    Date of Event
    January 12, 2022
    Report Date
    June 1, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS THAT WERE RELEASED ON THE MARKET WITH THE SAME LOT #S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS. THEREFORE, ALL THE PRODUCTS WITH THE SAME LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - DATED (B)(6) 2021 - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE PREOP REVISION RADIOGRAPH SHOWS AN ADVANCED OSTEOLYSIS AROUND THE GLENOID PEG IN THE GLENOID VAULT. BECAUSE THE INTRAOPERATIVE CULTURE WAS POSITIVE FOR C. ACNES THIS IS THE REASON FOR SEPTIC LOOSENING. THE REVISION THEREFORE IS DUE TO A FATEFUL PATIENT HISTORY BASED ON INFECTION AND NOT RELATED TO THE IMPLANT ITSELF". CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S - STER.; · ACCORDING TO THE REPORTED INFORMATION, THE GERM RESPONSIBLE FOR THE INFECTION WAS CUTIBACTERIUM ACNES; · THE MEDICAL EXPERT CONFIRMED THAT "THE PREOP REVISION RADIOGRAPH SHOWS AN ADVANCED OSTEOLYSIS AROUND THE GLENOID PEG" AND "BECAUSE THE INTRAOPERATIVE CULTURE WAS POSITIVE FOR C. ACNES THIS IS THE REASON FOR SEPTIC LOOSENING"; 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 (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 FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO INFECTION. IT WAS REPORTED THAT THE GERM RESPONSIBLE FOR THE INFECTION WAS CURTIBACTERIUM ACNES. THE FOLLOWING COMPONENTS WERE REMOVED: SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #1921968 - STER. 2000020). SMR REVERSE HP LINER LONG (PRODUCT CODE 1362.09.020, LOT #1908434 - STER. 1900265) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #1920750 - STER. 1900463). SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #2000397 - STER. 2000029) - PRODUCT NOT SOLD IN THE US. SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2004095 - STER. 2000092) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #1812982 - STER. 1800270). THE STEM WAS LEFT IN SITU. A CEMENT SPACER WAS IMPLANTED, AND A CUSTOMIZED GLENOID WAS REQUESTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A MALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6), 2022, DUE TO INFECTION. IT WAS REPORTED THAT THE GERM RESPONSIBLE FOR THE INFECTION WAS CUTIBACTERIUM ACNES. THE FOLLOWING COMPONENTS WERE REMOVED: · SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #1921968 - STER. 2000020). · SMR REVERSE HP LINER LONG (PRODUCT CODE 1362.09.020, LOT #1908434 - STER. 1900265) - PRODUCT NOT SOLD IN THE US · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #1920750 - STER. 1900463) · SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #2000397 - STER. 2000029) - PRODUCT NOT SOLD IN THE US · SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2004095 - STER. 2000092) - PRODUCT NOT SOLD IN THE US · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #1812982 - STER. 1800270) THE STEM WAS LEFT IN SITU. A CEMENT SPACER WAS IMPLANTED, AND A CUSTOMIZED GLENOID WAS REQUESTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2020. PATIENT IS A MALE, 72 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550033 SMR REVERSE FINNED HUMERAL BODY FINNED REVERSE HUMERAL BODY FOR TRAUMA KWS LIMACORPORATE S.P.A. 1352.15.050 1921968

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention