BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS MINI STEM

    MDR report key: 15362587 · Received September 6, 2022

    Report

    Report Number
    3008021110-2022-00080
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 26, 2022
    Report Date
    November 14, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    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 STERILIZED WITH THE SAME LOT #S. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS STERILIZED WITH THE SAME LOT #S. EXPLANTS ANALYSIS THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO POST-OPERATIVE OF PRIMARY SURGERY. THE X-RAY RECEIVED - DATED 10/08/2022 - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THIS IS A PRETTY MUCH CLEAR CASE OF PERIPROSTHETIC INFECTION; IT EXPLAINS THE BONE CHANGES AT THE PROXIMAL PART OF THE HUMERUS. THIS IS AN UNFAVOURITE FATEFUL CAUSE OF EVENTS. I CANNOT IDENTIFY ANY IMPLANT-RELATED ISSUES HERE". CONSIDERING THAT: · CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS STERILIZED WITH THE INVOLVED LOT #S - STER.; · ACCORDING TO THE MEDICAL EXPERT "THIS IS A PRETTY MUCH CLEAR CASE OF PERIPROSTHETIC INFECTION" AND "I CANNOT IDENTIFY ANY IMPLANT-RELATED ISSUES HERE"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESES 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 FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO INFECTION. IT WAS REPORTED THAT SPECIMENS WERE TAKEN, BUT RESULTS ARE UNKNOWN. THE FOLLOWING COMPONENTS WERE REMOVED: SMR CEMENTLESS MINI STEM (PRODUCT CODE 1304.15.120, LOT #2007038 - STER. 2000230). SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #2125761 - STER. 2200030). SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT #22AT0N5 - STER. 2200156) - PRODUCT NOT MARKETED IN THE US. SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #2213083 - STER. 2200172). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2212814 - STER. 2200165). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2212213 - STER. 2200156). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2209469 - STER. 2200152). NEW COMPONENTS WERE IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A FEMALE, 63 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON AUGUST 26TH, 2022, DUE TO INFECTION. IT WAS REPORTED THAT SPECIMENS WERE TAKEN, BUT RESULTS ARE UNKNOWN. THE FOLLOWING COMPONENTS WERE REMOVED: · SMR CEMENTLESS MINI STEM (PRODUCT CODE 1304.15.120, LOT #2007038 - STER. 2000230) · SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #2125761 - STER. 2200030). · SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT #22AT0N5 - STER. 2200156) - PRODUCT NOT MARKETED IN THE US. · SMR GLENOSPHERE Ø 36MM (PRODUCT CODE 1374.09.111, LOT #2213083 - STER. 2200172). · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2212814 - STER. 2200165). · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2212213 - STER. 2200156). · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2209469 - STER. 2200152). NEW COMPONENTS WERE IMPLANTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A FEMALE, 63 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287083 SMR CEMENTLESS MINI STEM FINNED HUMERAL STEMS - 60MM (TI6AL4V) DIA.12MM HSD LIMACORPORATE S.P.A. 1304.15.120 2007038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention