BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 8707717 · Received June 18, 2019

    Report

    Report Number
    3008021110-2019-00071
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    June 5, 2019
    Report Date
    June 18, 2019
    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

    DHR CHECK: BY CHECKING THE STERILIZATION CHARTS OF ALL THE LOT#S INVOLVED, NO ANOMALY WAS FOUND ON THE OVERALL NUMBER OF COMPONENTS MANUFACTURED. WE CAN THEN STATE ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: EXPLANTS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE. X-RAYS ANALYSIS: WE RECEIVED PRE-OP X-RAYS, TAKEN BEFORE THE FIRST STAGE REVISION SURGERY (EXACT DATE UNKNOWN). X-RAYS RECEIVED WERE EVALUATED BY OUR MEDICAL CONSULTANT AS PER FOLLOWING: "THE PROSTHESIS HAS LASTED 7 MONTHS ONLY BEFORE REVISION WAS CARRIED OUT SO WHILE IT WOULD STILL BE DEFINED AS A LATE INFECTION IT IS ALMOST CERTAIN THAT THE INFECTION OCCURRED AT THE TIME OF IMPLANTATION. WHILE THE X-RAY SHOWS A LARGE LYTIC AREA AROUND THE PEG OF THE AXIOMA WE CAN EXTRAPOLATE THAT THE GLENOID PROSTHESIS WAS IMPLANTED HIGH IN THE GLENOID BONE AND THERE IS EVIDENCE OF MARKED IMPINGEMENT. WE HAVE NO DATA ON WHAT THE INFECTING ORGANISM WAS BUT I WOULD SPECULATE A LOW VIRULENCE BACTERIA COMMENSURATE WITH THE 7 MONTHS SURVIVAL. I CANNOT SEE ANY OBVIOUS LYTIC REACTION AROUND THE HUMERAL COMPONENT. IN SUMMARY THE ARTHROPLASTY HAS BECOME INFECTED. THERE WAS A TECHNICAL ERROR WITH THE POSITIONING OF THE GLENOID COMPONENT TOO HIGH IN THE HOST GLENOID. THERE IS NO LITERATURE EVIDENCE LINKING IMPINGEMENT WITH INFECTION." CONCLUSION: BASED ON OUR ANALYSIS, EVEN IF THE CAUSE FOR THE INFECTION CANNOT BE CLEARLY IDENTIFIED, WE CAN SPECULATE THAT IT WAS NOT RELATED TO THE PRODUCTS THEMSELVES. ALL THE COMPONENTS HAD BEEN, IN FACT, PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. AN ERROR IN THE INITIAL PROSTHESIS PLACING WAS NOTED BY OUR MEDICAL CONSULTANT WHEN ANALYSING THE PRE-OP X-RAYS, HOWEVER IT DOES NOT SEEM RELATED TO THE INFECTION REPORTED. THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT-RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, SMR REVERSE REVISION RATE DUE TO INFECTION IS 0.06%. NO SPECIFIC ACTION FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FUTURE SIMILAR EVENT.

    Description of Event or Problem · 0

    FIRST STAGE REVISION SURGERY OF A SMR REVERSE PROSTHESIS DUE TO INFECTION OCCURRED ON (B)(6) 2019. PREVIOUS SURGERY OCCURRED ON (B)(6) 2018. IT WAS REPORTED THAT PREVIOUS SURGERY WAS ALSO A REVISION SURGERY (ROOT CAUSE UNKNOWN). PRIMARY SURGERY TOOK PLACE ON 2ND JUNE 2016. ACCORDING TO THE INFO REPORTED, THE SURGEON MENTIONED THAT THE PATIENT'S PASSIVE RANGE OF MOTION WAS GOOD DESPITE PAIN. DURING THE FIRST STAGE REVISION, ALL THE COMPONENTS WERE EXPLANTED AND A CEMENT SPACER WAS IMPLANTED. INVOLVED COMPONENTS AS PER FOLLOWS: SMR CEMENTLESS FINNED STEM CODE 130415230 LOT# 1807897 STER 1800182; SMR REVERSE HUMERAL BODY CODE 135220010 LOT# 1809868 STER 1800239; SMR REVERSE LINER STANDARD CODE 136050010 LOT# 18AT18R STER 1800203; SMR GLENOSPHERE Ø 36MM CODE 137409111 LOT# 1805746 STER 1800214; SMR CONNECTOR SMALL R CODE 137415305 LOT# 1813166 STER 1800278; SMR GLENOID PEG TT SMALL-R #L CODE 137514653 LOT# 1805747 STER 1800171; SMR GLENOID BASEPLATE SMALL-R CODE 137515605 LOT# 1811413 STER 1800266; CORTIC.BONE SCREW D.4,5 L.30MM CODE 843115030 LOT# 1808069 STER 1800163; CORTIC.BONE SCREW D.4,5 L.36MM CODE 843115036 LOT# 1702122 STER 1700339. SURGEON BELIEVED PROPIONIBACTERIUM ACNES (P ACNES) WAS RESPONSIBLE FOR THE INFECTION (SWABS HAVE BEEN SENT FOR ANALYSIS). TEST RESULTS HAVE NOT BEEN PROVIDED TO US. AT TODAY,NO ADDITIONAL DETAILS WERE PROVIDED TO LIMACORPORATE ABOUT SECOND STAGE OF THE REVISION SURGERY. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHART OF THE LOT #S INVOLVED, NO ANOMALY WAS FOUND. THEREFORE, WE CAN ENSURE THAT THE WHOLE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    FIRST STAGE REVISION SURGERY OF REVERSE SMR DUE TO INFECTION OCCURRED ON (B)(6) 2019. PRIMARY SURGERY OCCURRED ON (B)(6) 2018. ACCORDING TO THE INFO REPORTED, SURGEON MENTIONED THAT PATIENT PASSIVE RANGE OF MOVEMENT WAS GOOD DESPITE PAIN. DURING REVISION, ALL THE COMPONENTS WERE EXPLANTED AND A CEMENT SPACER WAS IMPLANTED. SURGEON BELIEVED THE INFECTION WAS PROPIONIBACTERIUM ACNES (P ACNES) AND SWABS HAVE BEEN SENT FOR SAMPLE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503030 SMR CEMENTLESS FINNED STEM SMR CEMENTLESS FINNED STEM (HSD-KWT ) HSD LIMACORPORATE S.P.A. 1304.15.230 1807897

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention