BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 10661057 · Received October 12, 2020

    Report

    Report Number
    3008021110-2020-00083
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    October 1, 2020
    Report Date
    April 13, 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. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. EXPLANTS ANALYSIS: EXPLANTED COMPONENT NOT AVAILABLE TO BE SENT BACK TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: WE RECEIVED SOME PRE-OP X-RAYS TAKEN ON SEPTEMBER 1ST, 2020. WE ASKED FOR A CLINICAL OPINION ABOUT THE CASE TO OUR MEDICAL CONSULTANT. FOLLOWING HIS STATEMENT: "THE X RAYS SHOW NO ISSUE WITH POSITIONING OF THE COMPONENTS. NOR IS THERE ANY OVERT X-RAY EVIDENCE OF LYSIS EXCEPT THE FIRST IMAGE WHERE THERE IS POSSIBLY SOME MINOR LYSIS AROUND THE INFERIOR SCREW? WHAT IS STRIKING IS THE HUMERAL STEM AND METAPHYSIS REMODELLING CHANGE AFTER LITTLE OVER A YEAR AND HALF SINCE THE INDEX PROCEDURE.THERE HAS BEEN NO EVIDENCE TO RELATE THESE CHANGES TO INFECTION. IT IS AS FAR AS WE KNOW A FUNCTION OF STEMMED PROSTHESES AND WITHOUT GOING INTO DETAIL SUFFICE TO SAY IS NOT SURGEON RELATED. IT ALSO IS NOT "BRAND SPECIFIC". THE SURGEON HAS MADE A JUDGEMENT TO LEAVE THE BASEPLATE IN SITU. WE DO NOT KNOW FURTHER DETAIL EG.WHETHER THIS WAS A "2 STAGE PROCEDURE" IN THE ONE SURGICAL EVENT OR OTHER. THAT SAID I WOULD STILL HAVE CONCERN WITH THIS SPECIFIC PATHOGEN WHICH IS VERY DIFFICULT TO ERADICATE AND THE CHOICE TO LEAVE THE BASEPLATE AND NOT DO A FORMAL 2 STAGE PROCEDURE. AGAIN, AS MENTIONED, IT IS A DIFFICULT INFECTION TO DEAL WITH WHATEVER PROCEDURE IS DONE SO I AM NOT OVERLY CRITICAL AND ESPECIALLY AS THERE IS NO DETAILS. IN SUMMARY THE PATIENT HAS SUFFERED A POSTOPERATIVE PROSTHETIC JOINT INFECTION WITH CUTI-BACTERIUM ACNES AND THIS IS A WELL RECOGNISED COMPLICATION AND RISK OF SHOULDER ARTHROPLASTY AND MORE SO IN REVERSE ARTHROPLASTY". STATING THAT: NO PRE-EXISTING ANOMALIES WERE FOUND BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED PRODUCTS; THE MEDICAL CONSULTANT HIGHLIGHTED THAT "...THE PATIENT HAS SUFFERED A POSTOPERATIVE PROSTHETIC JOINT INFECTION WITH CUTI-BACTERIUM ACNES AND THIS IS A WELL RECOGNISED COMPLICATION AND RISK OF SHOULDER ARTHROPLASTY AND MORE SO IN REVERSE ARTHROPLASTY" NO SPECIFIC ROOT CAUSE CAN BE ASSIGNED TO THIS CASE. BASED ON THE INVESTIGATION PERFORMED WE CANNOT CLASSIFY THIS EVENT AS PRODUCT RELATED. PMS DATA: REVISION RATE RELATED TO INFECTION OF SMR REVERSE PROSTHESIS IS 0.06%. NO SPECIFIC CORRECTIVE ACTIONS FOR THIS 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 REVERSE PROSTHESIS PERFORMED ON OCTOBER 1ST, 2020 DUE TO INFECTION. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT# 1810121 - STER. 1800249). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT# 1813644 - STER. 1800310). SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT# 17AT21T - STER. 1800240). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 1817954 - STER. 1800396). SMR ECCENT. GLENOSPHERE Ø 36MM (PRODUCT CODE 1376.09.031, LOT# 1805067 - STER. 1800189). THE BASEPLATE WAS LEFT IMPLANTED. IT WAS REPORTED THAT THERE WAS PRESENCE OF INFECTION DUE TO P. ACNES. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. PATIENT IS A FEMALE, BORN ON (B)(6)1939. NO ADDITIONAL CLINICAL INFO AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    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. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO PAIN PERFORMED ON (B)(6) 2020. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT# 1810121 - STER. (B)(4)). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT# 1813644 - STER. (B)(4)). SMR REVERSE LINER STANDARD (PRODUCT CODE 1360.50.010, LOT# 17AT21T - STER. (B)(4)). SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 1817954 - STER. (B)(4)). SMR ECCENT. GLENOSPHERE Ø 36MM (PRODUCT CODE 1376.09.031, LOT# 1805067 - STER. (B)(4)). THE BASEPLATE WAS LEFT IMPLANTED. SIMILAR COMPONENTS WERE IMPLANTED. IT WAS REPORTED THAT THERE WAS PRESENCE OF INFECTION DUE TO P. ACNES. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2019. PATIENT IS A FEMALE, BORN ON (B)(6). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131923 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM HSD LIMACORPORATE S.P.A. 1304.15.140 1810121

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention