BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM Ø22

    MDR report key: 8172791 · Received December 18, 2018

    Report

    Report Number
    3008021110-2018-00121
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    December 11, 2018
    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

    CHECK OF THE STERILIZATION CHARTS: THE CHECK OF THE STERILIZATION CHARTS DID NOT SHOW ANY PRE-EXISTING ANOMALY ON: A TOTAL OF 60 CEMENTLESS STEMS MANUFATURED WITH THE SAME LOT # AND STER. LOT#; A TOTAL OF 100 REVERSE HUMERAL BODIES MANUFACTURED WITH THE SAME LOT # AND STER#; A TOTAL OF 50 REVERSE LINERS PLACED ON THE MARKET WITH THE SAME LOT # AND STER#; A TOTAL OF 60 GLENOSPHERES PLACED ON THE MARKET WITH THE SAME LOT # AND STER#; A TOTAL OF 53 CEMENTLESS GLENOIDS PLACED ON THE MARKET WITH THE SAME LOT # AND STER. BY THE RESULTS OF THE OF THE STERILIZATION CHARTS ANALYSIS, WE CAN STATE THAT ALL THE PRODUCTS PREVIOUSLY IMPLANTED HAD BEEN CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT DUE TO INFECTION RECEIVED ON THESE LOT/STER. NUMBERS. EXPLANTS ANALYSIS: NO EXPLANTS AVAILABLE TO BE SENT TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: WE RECEIVED SOME X-RAYS DATED 11 DECEMBER 2018 (TAKEN JUST BEFORE THE REVISION SURGERY). WE SENT THEM TO OUR MEDICAL CONSULTANT FOR A CLINICAL JUDGMENT. FOLLOWING, THE MEDICAL OPINION RECEIVED: "FROM THE HISTORY IT SOUNDS THAT THE PATIENT HAD A GOOD FUNCTIONING REVERSE ARTHROPLASTY FROM THE TIME OF IMPLANTATION IN 2011 UP UNTIL 2018 AND SOME 6 WEEKS OR SO PRIOR TO EXPLANTATION. WHILE LOOSENING CAN BE A PRECURSOR TO INFECTION IF WE ACCEPT THIS PROSTHESIS WAS AS DESCRIBED FUNCTIONING WELL RIGHT UP TO EXPLANTATION THAT THE INFECTION WAS LIKELY BLOODBORNE AND UNRELATED TO ANY CONTAMINATION AT THE TIME OF IMPLANTATION. THIS THEREFORE IS THE SAME RISK THAT ANY PATIENT WHO UNDERGOES ARTHROPLASTY IN ANY JOINT TAKES". CONCLUSION: NO ADDITIONAL INFO PROVIDED (ESPECIALLY ABOUT GERM RESPONSIBLE FOR THE INFECTION OR PREVIOUS INFECTION EXPERIENCED BY THE SAME PATIENT). WITH THE ONLY INFO PROVIDED, A DEEPER ANALYSIS CANNOT BE DONE. BY THE ANALYSIS PERFORMED AND BY CONSIDERING A 7 YEARS IMPLANT SURVIVORSHIP, WE CAN STATE THAT THIS WAS NOT A PRODUCT RELATED CASE. INFECTION AS AN INTRINSIC RISK OF ARTHROPLASTY SHOULD BE TAKEN INTO ACCOUNT. PMS DATA: ACCORDING TO OUR PMS DATA, SMR REVERSE REVISION RATE DUE TO INFECTION IS (B)(4). NONE OF THE CASES WE COULD INVESTIGATE WERE CLASSIFIED AS PRODUCT RELATED. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    REVISION SURGERY OF A SMR REVERSE PROSTHESIS DUE TO INFECTION PERFORMED ON THE (B)(6) 2018. PREVIOUS SURGERY PERFORMED ON THE (B)(6) 2011. DURING THE REVISION SURGERY ALL THE COMPONENTS PREVIOUSLY IMPLANTED WERE REMOVED AND A CEMENT SPACER INSERTED. THE EXPLANTED COMPONENTS ARE THE FOLLOWING: SMR CEMENTLESS FINNED STEM Ø22 CODE 1304.15.220 LOT# 1005441 STER. 1000192. SMR REVERSE HUMERAL BODY CODE 1352.20.010 LOT# 1104979 STER. 1100200. SMR REVERSE LINER + 6 MM CODE 1360.50.020 LOT# 0904466 STER. 0900262. SMR GLENOSPHERE Ø36 MM CODE 1374.09.110 LOT# 0908936 STER. 1000003. CEMENTLESS GLENOID STD CODE 1375.25.070 LOT# 1105489 STER. 1100225. ACCORDING TO THE INFO REPORTED, INFECTION WAS SUSPECTED DUE TO REDNESS AND INFLAMMATION IN THE RIGHT ARM FOR SIX WEEKS PRIOR TO REVISION SURGERY. AFTER FOUR WEEKS, THE PATIENT HAD A WOUND WASHOUT AND ANTIBIOTIC TREATMENT IN A DIFFERENT HOSPITAL, BUT THE SYMPTHOMS PERSISTED AND THE PATIENT WAS REFERRED TO THE SURGEON OF THE CURRENT SURGERY. THE SURGEON REPORTED THAT BOTH THE GLENOID AND THE HUMERAL STEM WERE WELL FIXED. NO OTHER INFO REPORTED TO THE MANUFACTURER. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF ALL THE INVOLVED LOT#S NO ANOMALY WAS FOUND, MEANING THAT THESE COMPONENTS HAD BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY PERFORMED ON (B)(6) 2011. DURING REVISION ALL THE COMPONENTS HAVE BEEN REMOVED AND SPACER INSERTED. THE EXPLANTED COMPONENTS ARE THE FOLLOWING: SMR CEMENTLESS FINNED STEM Ø22 CODE 1304.15.220 LOT# 1005441 STER. 1000192; SMR REVERSE HUMERAL BODY CODE 1352.20.010 LOT# 1104979 STER. 1100200; SMR REVERSE LINER + 6 MM CODE 1360.50.020 LOT# 0904466 STER. 0900262; SMR GLENOSPHERE Ø36 MM CODE 1374.09.110 LOT# 0908936 STER. 1000003; CEMENTLESS GLENOID STANDARD CODE 1375.25.070 LOT# 1105489 STER. 1100225. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013956 SMR CEMENTLESS FINNED STEM Ø22 FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.22MM (HSD-KWT) HSD LIMACORPORATE S.P.A. 1304.15.220 1005441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention