BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL EXTENSION + 9 MM

    MDR report key: 7917730 · Received September 28, 2018

    Report

    Report Number
    3008021110-2018-00080
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    June 27, 2019
    Report Date
    July 15, 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

    CHECK OF THE DHR: BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOTS, NO PRE-EXISTING ANOMALY WAS FOUND, THUS WE CAN STATE THAT ALL THE COMPONENTS PLACED ON THE MARKET WITH THESE LOTS HAVE BEEN PROPERLY STERILIZED. NO EXPLANTS NOR PICTURES OF EXPLANTS AVAILABLE TO BE RETURNED TO LIMA CORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: X-RAY IMAGES NOT AVAILABLE FOR FURTHER INVESTIGATION. BASED ON THE VERY FEW INFO REPORTED WE ARE NOT ABLE TO FIND THE ROOT CAUSE OF THIS EVENT. HOWEVER, BASED ON THE ANALYSIS OF THE STERILIZATION CHARTS, WE CAN SPECULATE THAT THIS EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, SMR REVERSE REVISION RATE DUE TO INFECTION IS 0.056%. NONE OF THE CASES WE COULD INVESTIGATE WERE CLASSIFIED AS PRODUCT RELATED. NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMA CORPORATE WILL KEEP MONITORED THE MARKET.

    Description of Event or Problem · 0

    SMR REVERSE FIRST STAGE REVISION SURGERY PERFORMED ON THE (B)(6) 2019 DUE TO INFECTION. PREVIOUS SURGERY WAS PERFORMED ON THE (B)(6) 2018. DURING REVISION, THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL EXTENSION + 9 MM, COD. 1352.15.001, LOT #1708847, STER.1700307 SMR REV. HP LAT. LINER MEDIUM, NOT MARKED IN USA SMR CONNECTOR SMALL R, COD. 1374.15.305, LOT #1714813, STER.1800023 SMR REVERSE HP GLENOSPH. 40 MM, NOT MARKED IN USA SMR UNCEMENT. GLENOID #SMALL-R, NOT MARKED IN USA BONE SCREW Ø6,5 H.20MM, COD. 8420.15.010 LOT #1714175, STER.1800005 BONE SCREW Ø6,5 H.20MM, COD.8420.15.010, LOT #1713908, STER.1700394 BASICALLY, DURING THE FIRST STAGE REVISION GLENOID-SIDE COMPONENTS WERE EXPLANTED TO CONVERT TO HEMI: A CTA HEAD WAS IMPLANTED. ACCORDING TO OUR COMPLAINT SOURCE A SECOND STAGE REVISION WILL BE PERFORMED BUT NO INFO ABOUT FUTURE SURGERY DATE WAS PROVIDED NO PREVIOUS CASES OF INFECTION REPORTED FOR THIS PATIENT. X-RAYS IMAGES AND SWAB ANALYSIS WERE REQUESTED BY LIMA BUT THEY WERE NOT AVAILABLE. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO PRE EXISTING ANOMALY WAS FOUND ON THE (B)(4) PIECES PLACED ON THE MARKET WITH LOT#16AG0A1C. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE WITH A PHYSICA TIBIAL POSITIONER (CODE 9065.88.130, LOT# 16AG0A1C): A LITTLE PIECE OF THE INSTRUMENT CAME OFF ITS TERMINAL PART. EVENT HAPPENED IN SPRING 2018, EXACT DATA UNKNOWN. THIS BREAKAGE CAUSED NO CONSEQUENCES FOR THE PATIENT NOR PROLONGED SURGERY TIME. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758191 SMR HUMERAL EXTENSION + 9 MM SMR HUMERAL EXTENSION + 9 MM KWS LIMACORPORATE SPA 1352.15.001 1708847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention