BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 8644176 · Received May 27, 2019

    Report

    Report Number
    3008021110-2019-00062
    Event Type
    Injury
    Date Received
    May 27, 2019
    Date of Event
    May 15, 2019
    Report Date
    September 24, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE STERILIZATION CHARTS OF THE LOT/STER. #S INVOLVED, NO ANOMALY WAS FOUND: ON A TOTAL OF 1 SMR REVERSE HUMERAL BODY MANUFACTURED WITH LOT #1209160, STER.1700190; ON A TOTAL OF 80 SMR REVERSE HP LINER MANUFACTURED WITH LOT #1703661, STER.1700144 (NOT MARKED IN USA); ON A TOTAL OF 53 SMR CONNECTOR MANUFACTURED WITH LOT #1801329, STER.1800058; ON A TOTAL OF 30 SMR REVERSE HP GLENOSPHERES MANUFACTURED WITH LOT #1800170, STER.1800024 (NOT MARKED IN USA); ON A TOTAL OF 59 SMR GLENOID PEG TT MANUFACTURED WITH LOT #1615386, STER.1700025; ON A TOTAL OF 45 SMR GLENOID BASEPLATES MANUFACTURED WITH LOT #1405580, STER.1400132. THEREFORE, WE CAN STATE ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. CT-SCANS ANALYSIS: WE RECEIVED THE PRE-OP REVISION SURGERY CT-SCANS (DATED EARLY MAY 2019, EXACT DATE UNKNOWN) AND SENT THEM TO OUR MEDICAL CONSULTANT. HE COMMENTED: "THE ONLY COMMENT I CAN MAKE IS THE IMAGES (CT SCANS) SHOW EVIDENCE OF BONEY RESORPTION AROUND BOTH THE GLENOID AND HUMERAL COMPONENTS. THIS IS CONSISTENT WITH INFECTION [[?]] WITHOUT FURTHER INFORMATION ON THE PATIENT'S RISK PROFILE I CANNOT MAKE FURTHER COMMENT." THEREFORE, OUR MEDICAL CONSULTANT CONFIRMED THE PRESENCE OF THE INFECTION, ALTHOUGH WITHOUT ANY FURTHER INFORMATION HE COULD NOT SPECULATE THE ROOT CAUSE OF THE INFECTION. STATING THAT: NO ANOMALY WAS FOUND BY CHECKING THE STERILIZATION CHARTS OF THE ALL COMPONENTS INVOLVED; NO EXPLANTS AVAILABLE TO BE RETURNED TO LIMACORPORATE; OUR MEDICAL CONSULTANT CONFIRMED THE PRESENCE OF INFECTION. WE CAN CONCLUDE THAT THIS EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, REVISION RATE OF SMR REVERSE SYSTEM DUE TO INFECTION IS 0.06%. 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

    SHOULDER REVISION SURGERY DUE TO INFECTION OCCURRED ON MAY 15, 2019. PREVIOUS SURGERY WAS PERFORMED ON APRIL 18, 2018. ACCORDING TO THE INFO REPORTED, ROOT CAUSE OF INFECTION IS UNKNOWN. DURING THE REVISION SURGERY, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY SHORT, CODE 1352.15.005, LOT #1209160, STER.1700190; SMR REVERSE HP LINER MEDIUM, NOT MARKED IN USA; SMR CONNECTOR SMALL STD, CODE 1374.15.310, LOT #1801329, STER.1800058; SMR REVERSE HP GLENOSPH. 44 MM, NOT MARKED IN USA; SMR GLENOID PEG TT S/STD/L #M, CODE 1375.14.662, LOT #1615386, STER.1700025; SMR GLENOID BASEPLATE SMALL, CODE 1375.15.620, LOT #1405580, STER.1400132. SURGEON PERFORMED A WASHOUT OF THE JOINT AND NEW COMPONENTS WERE IMPLANTED (EXACT PRODUCT CODES UNKNOWN). PATIENT IS 75 YEARS OLD. NO FURTHER INFO PROVIDED BY THE COMPLAINT SOURCE. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE LOT #S INVOLVED, NO ANOMALY WAS FOUND. THEREFORE, WE CAN STATE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS FIRST AND CASE OF INFECTION RECEIVED WITH THESE LOT#S/STER. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION OCCURRED ON (B)(6) 2019. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2019. ACCORDING TO THE INFO REPORTED, ROOT CAUSE OF INFECTION IS UNKNOWN. DURING REVISION, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY SHORT, CODE 1352.15.005, LOT #1209160, STER.1700190; SMR REVERSE HP LINER MEDIUM, CODE 1362.09.015, LOT #1703661, STER.1700144; SMR CONNECTOR SMALL STD, CODE 1374.15.310, LOT #1801329, STER.1800058; SMR REVERSE HP GLENOSPH. 44 MM, CODE 1374.50.440, LOT #1800170, STER.1800024; SMR GLENOID PEG TT S/STD/L #M, CODE 1375.14.662, LOT #1615386, STER.1700025; SMR GLENOID BASEPLATE SMALL, CODE 1375.15.620, LOT #1405580, STER.1400132. SURGEON PERFORMED A WASHOUT OF THE JOINT AND IMPLANTED NEW COMPONENTS. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437755 SMR REVERSE HUMERAL BODY SHORT SMR REVERSE HUMERAL BODY SHORT KWS LIMACORPORATE SPA 1352.15.005 1209160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention