BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL STD

    MDR report key: 13535640 · Received February 15, 2022

    Report

    Report Number
    3008021110-2022-00006
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    February 1, 2022
    Report Date
    June 21, 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 PLACED 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 A TOTAL OF TWO X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - DATED 31/01/2022 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE RADIOGRAPHS LOOK FINE. THE INFECTION IS THE MAIN CAUSE FOR REVISION OF THE IMPLANT. I CANNOT SEE ANY SIGN FOR IMPLANT RELATED ISSUES HERE". CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S; · A LOW-GRADE INFECTION BY PROPIONIBACTERIUM WAS CONFIRMED BY CULTURE TESTS; · ACCORDING TO THE MEDICAL CONSULTANT "THE RADIOGRAPHS LOOK FINE. THE INFECTION IS THE MAIN CAUSE FOR REVISION OF THE IMPLANT"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE 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 IMPLANT PERFORMED ON (B)(6) 2022, DUE TO INFECTION. IT WAS REPORTED THAT PATIENT HAD ONGOING AND INCREASING PAIN. ACCORDING TO THE COMPLAINT SOURCE, CULTURES WERE TAKEN, AND RESULTS CONFIRMED A LOW-GRADE INFECTION BY PROPRIONIBACTERIUM. A TWO-STAGE REVISION WAS PLANNED: ALL COMPONENTS EXCEPT FOR METAL BACK AND STEM WERE REMOVED, FOLLOWED BY A COURSE OF ANTIBIOTICS: SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #1918564 - STER. 1900429) - PRODUCT NOT SOLD IN THE US. SMR REVERSE HP LATERALIZING LINER MEDIUM (PRODUCT CODE 1362.09.115, LOT #1908291 - STER. 1900256) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1905867 - STER. 1900134). SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #1920595 - STER. 1900424) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #1914481 - STER. 1900354). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #1914499 - STER. 1900354). IT WAS REPORTED THAT METAL BACK AND STEM WERE TOO WELL FIXED TO BE REMOVED WITHOUT SIGNIFICANT BONE LOSS. A CEMENT SPACER WAS PLACED IN HUMERUS DURING THE INTERIM PERIOD TO 2ND STAGE OF THE REVISION. 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 IMPLANT PERFORMED ON (B)(6), 2022, DUE TO INFECTION. IT WAS REPORTED THAT PATIENT HAD ONGOING AND INCREASING PAIN. ACCORDING TO THE COMPLAINT SOURCE, CULTURES WERE TAKEN, AND RESULTS CONFIRMED A LOW-GRADE INFECTION BY PROPIONIBACTERIUM. A TWO-STAGE REVISION WAS PLANNED. ON FIRST STAGE THE FOLLOWING COMPONENTS WERE REMOVED, FOLLOWED BY A COURSE OF ANTIBIOTICS: · SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #1918564 - STER. 1900429) - PRODUCT NOT SOLD IN THE US. · SMR REVERSE HP LATERALIZING LINER MEDIUM (PRODUCT CODE 1362.09.115, LOT #1908291 - STER. 1900256) - PRODUCT NOT SOLD IN THE US. · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #1905867 - STER. 1900134). · SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #1920595 - STER. 1900424) - PRODUCT NOT SOLD IN THE US. · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #1914481 - STER. 1900354). · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #1914499 - STER. 1900354). IT WAS REPORTED THAT METAL BACK AND STEM WERE TOO WELL FIXED TO BE REMOVED WITHOUT SIGNIFICANT BONE LOSS. A CEMENT SPACER WAS PLACED IN HUMERUS DURING THE INTERIM PERIOD TO 2ND STAGE OF THE REVISION, WHICH TOOK PLACE ON (B)(6), 2022. NEW COMPONENTS HAD THEN BEEN IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2020. PATIENT IS A MALE, 67 YEARS OLD. IT WAS REPORTED HE HAS A BMI OF 30, AND HE'S MODERATELY ACTIVE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777548 SMR CONNECTOR SMALL STD CONNECTOR WITH SCREW SMALL-STD KWS LIMACORPORATE S.P.A. 1374.15.310 1905867

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other