BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 12244217 · Received July 29, 2021

    Report

    Report Number
    3008021110-2021-00058
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    July 21, 2021
    Report Date
    December 7, 2021
    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

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. ALL THE PRODUCTS PLACED ON THE MARKET WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTED ITEMS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - DATED (B)(6) 2021 - HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE INDEX SURGERY WAS FOR A FRACTURE SO WE CANNOT CRITICIZE SELECTION OF THE PATIENT WITH SERIOUS CO-MORBIDITIES (WHICH I AM ASSUMING). THE XRAY IS TERRIBLE! IT SHOWS SOME FRAGMENTS OF BONE WHICH I ASSUME ARE TUBEROSITIES BECAUSE THE HUMERAL BODY HAS NO ADJACENT BONE. I AM GUESSING THAT THESE TUBEROSITIES WERE NOT REATTACHED WHICH IF SO WOULD BE AN ERROR BUT WOULD NOT PREVENT INFECTION. THE LOOSENING MAY WELL BE ENTIRELY DUE TO INFECTION BUT INFECTION DOES NOT NECESSARILY GO ONTO MACROSCOPIC FAILURE OF THE GLENOID COMPLEX. IN SUMMARY: IN A PATIENT WITH CO-MORBIDITIES THAT MIGHT COMPROMISE IMMUNE STATUS "PATIENT FACTORS" HAVE TO BE A SIGNIFICANT CONTRIBUTOR TO THE EARLY POST OPERATIVE INFECTION. IF THE TUBEROSITIES WERE NOT REATTACHED I WOULD BE CRITICAL OF THAT BUT THAT WOULD NOT PREVENT THE FAILURE OF FIXATION OF THE GLENOID". CONSIDERING THAT: · CHECK OF STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S; · ACCORDING TO THE MEDICAL CONSULTANT, "IN A PATIENT WITH CO-MORBIDITIES THAT MIGHT COMPROMISE IMMUNE STATUS "PATIENT FACTORS" HAVE TO BE A SIGNIFICANT CONTRIBUTOR TO THE EARLY POST OPERATIVE INFECTION"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS 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

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6), 2021, DUE TO SUSPECTED INFECTION. ACCORDING TO THE REPORTED INFORMATION, THE GLENOID COMPONENT WAS LOOSE. ALL IMPLANTS HAD BEEN REMOVED: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.200, LOT #2013346 - STER. 2000327). · SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #2019066 - STER. 2000397) - PRODUCT NOT MARKETED IN THE US. · SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010. LOT #2101507 - STER. 2100089) - PRODUCT NOT MARKETED IN THE US. · SMR REVERSE HP LAT. LINER LONG (PRODUCT CODE 1365.09.120, LOT #2005954 - STER. 2000208) - PRODUCT NOT MARKETED IN THE US. · SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2025211 - STER. 2100084). · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2100613 - STER. 2100035) - PRODUCT NOT MARKETED IN THE US. · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2101276 - STER. 2100048). · BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #1922838 - STER. 2000017). AN ANTIBIOTIC CEMENT SPACER WAS INSERTED. NO FURTHER DETAILS ON THE INFECTION WERE AVAILABLE. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2021. PATIENT IS A MALE, 66 YEARS OLD. IT WAS REPORTED HE IS OBESE AND HAS LIVER DISEASE. LOW LEVEL OF ACTIVITY. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS WITH THE SAME LOT #S. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2021, DUE TO SUSPECTED INFECTION. ACCORDING TO THE REPORTED INFORMATION, THE GLENOID COMPONENT WAS LOOSE. ALL IMPLANTS HAD BEEN REMOVED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.200, LOT #2013346 - STER. 2000327). SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #2019066 - STER. 2000397) - PRODUCT NOT MARKETED IN THE US. SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010. LOT #2101507 - STER. 2100089) - PRODUCT NOT MARKETED IN THE US. SMR REVERSE HP LAT. LINER LONG (PRODUCT CODE 1365.09.120, LOT #2005954 - STER. 2000208) - PRODUCT NOT MARKETED IN THE US. SMR CONNECTOR SMALL STD (PRODUCT CODE 1374.15.310, LOT #2025211 - STER. 2100084). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2100613 - STER. 2100035) - PRODUCT NOT MARKETED IN THE US. BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2101276 - STER. 2100048). BONE SCREW Ø6,5 H.35MM (PRODUCT CODE 8420.15.040, LOT #1922838 - STER. 2000017). AN ANTIBIOTIC CEMENT SPACER WAS INSERTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A MALE, (B)(6) YEARS OLD. IT WAS REPORTED HE IS OBESE AND HAS LIVER DISEASE. LOW LEVEL OF ACTIVITY. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147205 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.20MM HSD LIMACORPORATE S.P.A. 1304.15.200 2013346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other