BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER FOR METAL BACK GLENOID STANDARD

    MDR report key: 10885218 · Received November 23, 2020

    Report

    Report Number
    3008021110-2020-00096
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    November 4, 2020
    Report Date
    May 28, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K113254
    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. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED BY THREE TIMES TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; AVAILABILITY OF THE EXPLANTS; FURTHER DETAILS ON THE INFECTION; PICTURES OF EXPLANTS. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT BY THE CHECK OF THE STERILIZATION CHARTS NO ANOMALIES WERE FOUND ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #S INVOLVED, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR ANATOMIC PROSTHESIS DUE TO INFECTION IS (B)(4). NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC 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

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC PROSTHESIS PERFORMED ON (B)(6) 2020 DUE TO SUSPECTED INFECTION. THE PRIMARY ISSUE WAS CUFF TEAR, HOWEVER THE SMR UNCEMENTED GLENOID (PRODUCT CODE 1375.20.010, LOT# 1212299 - STER. 1200344) WAS LOOSE AT SURGERY. ACCORDING TO THE COMPLAINT SOURCE, PATIENT APPEARED TO HAVE A POSSIBLE LOW-GRADE INFECTION ONLY AROUND THE GLENOID COMPONENT. THE FOLLOWING COMPONENTS WERE REMOVED: SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT# 1212299 - STER. 1200344) - PRODUCT NOT MARKETED IN THE US . LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT# 1212426 - STER. 1200324). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT# 1212678 - STER. 1200337). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT# 1206859 - STER. 1200239). A CEMENT SPACER WAS INSERTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2012. PATIENT IS A MALE. 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. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6), 2020. THE PRIMARY ISSUE WAS CUFF TEAR, HOWEVER THE SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT# 1212299 - STER. 1200344) WAS LOOSE AT SURGERY. ACCORDING TO THE COMPLAINT SOURCE, PATIENT APPEARED TO HAVE A POSSIBLE LOW-GRADE INFECTION ONLY AROUND THE GLENOID. THE FOLLOWING COMPONENTS WERE REMOVED: LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT# 1212426 - STER. 1200324). SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT# 1212299 - STER. 1200344) - PRODUCT NOT MARKETED IN THE US. BONE SCREW 6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT# 1212678 - STER. 1200337). BONE SCREW 6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT# 1206859 - STER. 1200239). A CEMENT SPACER WAS INSERTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2012. PATIENT IS A MALE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348173 LINER FOR METAL BACK GLENOID STANDARD LINER FOR METAL-BACK (UHMWPE) LINER STANDARD KWS LIMACORPORATE S.P.A. 1377.50.010 1212426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention