BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 10784744 · Received November 4, 2020

    Report

    Report Number
    3008021110-2020-00095
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    June 30, 2020
    Report Date
    October 26, 2021
    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

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. VERY FEW INFO AVAILABLE ON THIS CASE: · CAUSE OF INFECTION IS UNKNOWN; · NO EXPLANTS AVAILABLE TO BE SENT BACK TO LIMACORPORATE FOR FURTHER ANALYSIS; · NO FURTHER INFO OTHER THAN THE SURGEON REQUESTED FOR A CUSTOM MADE COMPONENT TO BE IMPLANTED: WE CAN ONLY STATE THAT BASED ON THE CHECK OF THE RELEVANT DHR OF THE PRODUCT, THIS COMPLAINT CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR ANATOMIC SYSTEM 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

    REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2020 DUE TO INFECTION. ACCORDING TO THE COMPLAINT SOURCE, FOLLOWING THE INDEX ARTHROPLASTY AT A CERTAIN TIME THE PATIENT BECAME INFECTED AND SUBSEQUENTLY UNDERWENT REMOVAL OF ALL THE COMPONENTS PREVIOUSLY IMPLANTED ON (B)(6), 2020: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT# 1913458 - STER. 1900406). · SMR HUMERAL HEAD D.48 H.20MM (PRODUCT CODE 1324.09.481, LOT# 1701879 - STER. 1700153). · SMR ECCENTRICAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.272, LOT# 1911737 - STER. 1900318). · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT# 1920701 - STER. 2000016). · TT HYBRID CEM. GLENOID STD (PRODUCT CODE 1379.59.210, LOT# 1923071 - STER. 2000012). THE CAUSE OF THE INFECTION IS UNKNOWN. A CEMENTED SPACER WAS IMPLANTED. SURGEON REQUESTED FOR A CUSTOMIZED GLENOID COMPONENT. PATIENT IS AN ACTIVE MALE, 59 YEARS OLD, 70 INCHES, 186 LBS. EVENT HAPPENED IN THE US. TO DATE, WE ARE AWARE OF AN ADDITIONAL REVISION SURGERY INVOLVING THE SAME PATIENT (LIMACORPORATE COMPLAINT #(B)(4) REPORTED TO FDA THROUGH EXPANDED ACCESS PROGRAM FOR COMPASSIONATE USE DEVICES - (B)(4)).

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS, NO PRE-EXISTING ANOMALIES WERE FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS HAD BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT THE FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2020 DUE TO INFECTION. ACCORDING TO THE COMPLAINT SOURCE, SOME TIME FOLLOWING THE INDEX ARTHROPLASTY THE PATIENT BECAME INFECTED AND SUBSEQUENTLY UNDERWENT REMOVAL OF ALL IMPLANTS: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT# 1913458 - STER. 1900406). SMR HUMERAL HEAD D.48 H.20MM (PRODUCT CODE 1324.09.481, LOT# 1701879 - STER. 1700153). SMR ECCENTRICAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.272, LOT# 1911737 - STER. 1900318). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT# 1920701 - STER. 2000016). TT HYBRID CEM. GLENOID STD (PRODUCT CODE 1379.59.210, LOT# 1923071 - STER. 2000012). THE CAUSE OF THE INFECTION IS UNKNOWN. A CEMENTED SPACER WAS IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2020. PATIENT IS A MALE, (B)(6) YEARS OLD. EVENT HAPPENED IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252365 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.18MM HSD LIMACORPORATE S.P.A. 1304.15.180 1913458

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention