BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL STD

    MDR report key: 17304881 · Received July 12, 2023

    Report

    Report Number
    3008021110-2023-00086
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    May 16, 2023
    Report Date
    July 12, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    K110598
    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 LIMACORPORATE 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 FOR ANALYSIS. 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: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS DUE TO INFECTION IS 0.076%. 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 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 IMPLANT LOOSENING. ACCORDING TO THE RECEIVED INFORMATION, SWABS WERE TAKEN AND ULTIMATELY INFECTION CAUSED THE SEPTIC LOOSENING. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #2110802 - STER. 2100199) - PRODUCT NOT SOLD IN THE US. BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2114881- STER. 2100236). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2110531 - STER. 2100272). SMR REVERSE HP LINER LONG (PRODUCT CODE 1362.09.020, LOT #2117877 - STER. 2100302) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2023980 - STER. 2100079) SMR REVERSE HP CORRECTIVE GLENOSPHERE (PRODUCT CODE 1374.50.444, LOT #2120640 - STER. 2100311) - PRODUCT NOT SOLD IN THE US. THE PROSTHESIS WAS CONVERTED TO A SMR HEMI IMPLANT. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A MALE, 79 YEARS OLD. SURGEON KEEPS MONITORING THE HEMI PROSTHESIS IN PLACE. IT WAS REPORTED PATIENT IS CURRENTLY AWAITING SPINAL SURGERY THAT IS PRIORITY. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748922 SMR CONNECTOR SMALL STD CONNECTOR WITH SCREW SMALL-STD PHX LIMACORPORATE S.P.A. 1374.15.310 2023980

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention