BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER FOR METAL BACK GLENOID STANDARD

    MDR report key: 15742991 · Received November 7, 2022

    Report

    Report Number
    3008021110-2022-00113
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    October 27, 2022
    Report Date
    March 29, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#: 0901573, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT#. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #0901573 - STER. 0900224, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 25 ITEMS MANUFACTURED WITH THE SAME LOT # - STER. ACCORDING TO OUR RECORDS, AT LEAST 12 OUT OF 25 L1 LINERS WITH LOT #0901573 - STER. 0900224 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS ANALYSIS THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. SHARED PICTURES OF EXPLANTED COMPONENTS SHOW THAT THE METALBACK IS WORN AND DAMAGED, HOWEVER NO ADDITIONAL INFORMATION IS AVAILABLE ON WHAT COULD HAVE OCCURRED TO IT. X-RAYS ANALYSIS LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS AND ONE CT SCAN REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS AND CT SCAN RECEIVED - DATED (B)(6) 2022 - AND A COUPLE OF PICTURES OF THE EXPLANTED DEVICES HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THIS PATIENT UNDERWENT THE NORMAL COURSE OF A TSA WITH ROTATOR CUFF FAILURE OVER TIME, AT THE TIME OF REVISION HE IS 80Y OLD. THE RADIOGRAPH SHOWS THE ANTERO-SUPERIOR ESCAPE DUE TO RC FAILURE. THE SUBSEQUENT DAMAGE OF THE LINER AND THE BASEPLATE ARE THE RESULT OF THIS SCENARIO, NOT THE CAUSE. THERE IS NO SIGN FOR IMPLANT FAILURE". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT #0901573; · THE PROSTHESIS HAD BEEN IN PLACE FOR 13 YEARS; · ACCORDING TO THE MEDICAL CONSULTANT "THIS PATIENT UNDERWENT THE NORMAL COURSE OF A TSA WITH ROTATOR CUFF FAILURE OVER TIME" AND "THE SUBSEQUENT DAMAGE OF THE LINER AND THE BASEPLATE ARE THE RESULT OF THIS SCENARIO, NOT THE CAUSE"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. THE EVENT IS DUE TO PATIENT'S CONDITION. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF L1 GLENOID LINERS - BELONGING TO THE FAMILY CODES 1377.50.005 + 1377.50.010 + 1377.50.020 + 1377.50.030 - DUE TO WEAR IS 0.11%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, 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 PERFORMED ON (B)(6) 2022, DUE TO WEAR OF THE LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE: 1377.50.010, LOT#: 0901573 - STER.: (B)(4). THE FOLLOWING COMPONENTS WERE REMOVED: LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE: 1377.50.010, LOT#: 0901573 - STER.: (B)(4). SMR UNCEMENTED GLENOID # STD (PRODUCT CODE: 1375.20.010, LOT#: 0904523 - STER.: (B)(4) - PRODUCT NOT SOLD IN THE US. SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE: 1322.09.480, LOT#: 0900660 - STER.: (B)(4). SMR FINNED HUMERAL BODY (PRODUCT CODE: 1350.15.110, LOT#: 0902887 - STER.: (B)(4). BONE SCREW Ø6,5 H.20MM (PRODUCT CODE: 8420.15.010, LOT#: 0904092 - STER.: (B)(4). BONE SCREW Ø6,5 H.30MM (PRODUCT CODE: 8420.15.030, LOT#: 0400684 - STER.: (B)(4). THE PROSTHESIS WAS CONVERTED TO REVERSE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2009. PATIENT IS A MALE, 80 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO WEAR OF THE LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT #0901573 - STER. 0900224). THE FOLLOWING COMPONENTS WERE REMOVED: · LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT #0901573 - STER. 0900224) · SMR UNCEMENTED GLENOID # STD (PRODUCT CODE 1375.20.010, LOT #0904523 - STER. 0900235) - PRODUCT NOT SOLD IN THE US · SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE 1322.09.480, LOT #0900660 - STER. 0900144) · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #0902887 - STER. 0900243) · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #0904092 - STER. 0900220) · BONE SCREW Ø6,5 H.30MM (PRODUCT CODE 8420.15.030, LOT #0400684 - STER. 0900160) THE PROSTHESIS WAS CONVERTED TO REVERSE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2009. PATIENT IS A MALE, 80 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169223 LINER FOR METAL BACK GLENOID STANDARD LINER FOR METAL-BACK (UHMWPE) LINER STANDARD KWS LIMACORPORATE S.P.A. 1377.50.010 0901573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention