BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 17630220 · Received August 28, 2023

    Report

    Report Number
    3008021110-2023-00104
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 15, 2023
    Report Date
    August 23, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICES. THEREFORE, THE PRODUCTS WITH THESE LOT#S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMA CORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE ACCESSIBLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2023, DUE TO INFECTION. IT WAS REPORTED THAT ALL IMPLANTS WERE LOOSE AND GOT EASILY EXPLANTED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE: 1304.15.150, LOT#: 2208628 - STER. 2200146). SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT#: 2206829 - STER. 2200113). SMR REVERSE HP LINER SHORT (PRODUCT CODE: 1365.09.010, LOT#: 2211966 - STER. 2200172) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL R (PRODUCT CODE: 1374.15.305, LOT#: 2213987 - STER. 2200168). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE: 1374.50.400, LOT#: 2212450 - STER. 2200167) - PRODUCT NOT SOLD IN THE US. SMR UNCEMENTED GLENOID#: SMALL-R (PRODUCT CODE: 1375.20.005, LOT#: 2212986 - STER. 2200188) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE: 8420.15.010, LOT#: 2104282 - STER. 2100115). · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE: 8420.15.020, LOT#: 2210836 - STER. 2200164). A CEMENTED SPACER WAS PLACED IN, AND A SECOND SURGERY IS GOING TO BE PLANNED. SPECIMEN SAMPLES WERE TAKEN HOWEVER THE RESULTS AREN'T YET AVAILABLE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A FEMALE. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317835 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM HSD LIMACORPORATE S.P.A. 1304.15.150 2208628

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention