BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 15860253 · Received November 24, 2022

    Report

    Report Number
    3008021110-2022-00123
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    March 15, 2022
    Report Date
    November 23, 2022
    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 LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE PATHOGEN RESPONSIBLE FOR THE INFECTION AND ANY PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY. 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 (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 COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    WE BECAME AWARE OF A SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO INFECTION. ALL THE IMPLANTS GOT REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT #2110020 - STER. 2100209). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2115113 - STER. 2100246). SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2105477 - STER. 2100158) - PRODUCT NOT SOLD IN THE US. SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2109955 - STER. 2100198) - PRODUCT NOT SOLD IN THE US. CMD 21-1225 GLENOID IMPLANT (PRODUCT CODE 9618.16.002, LOT #2118264 - STER. 2100274) - CUSTOMIZED IMPLANT. CORTICAL BONE SCREW D.4,5 L.26MM (PRODUCT CODE 8431.15.026, LOT #2015480 - STER. 2000318). CORTICAL BONE SCREW D.4,5 L.30MM (PRODUCT CODE 8431.15.030, LOT #2007936 - STER. 2000214). CORTICAL BONE SCREW D.4,5 L.32MM (PRODUCT CODE 8431.15.032, LOT #2016860 - STER. 2000338). A HEMI PROSTHESIS WITH CTA HEAD WAS IMPLANTED. THE SURGEON REQUESTED A CUSTOMIZED IMPLANT FOR THE GLENOID. IT WAS REPORTED THAT THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A FEMALE, 80 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2732917 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM HSD LIMACORPORATE S.P.A. 1304.15.140 2110020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other