BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD 52 MM

    MDR report key: 10725866 · Received October 23, 2020

    Report

    Report Number
    3008021110-2020-00088
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    October 13, 2020
    Report Date
    April 13, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHR OF THE LOT #0703348, NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THIS LOT #. EXPLANTS ANALYSIS: EXPLANTED COMPONENTS NOT AVAILABLE TO BE RETURNED TO HQ. THE HOSPITAL DOES NOT PERMIT RETURN OF EXPLANTED PROSTHESES AS PER THEIR POLICY. X-RAYS ANALYSIS: WE RECEIVED SOME PRE-OPERATIVE X-RAYS TAKEN ON SEPTEMBER 21ST, 2020 + SOME PICTURES OF THE EXPLANTS SHOWING THE LINER'S WEAR. WE ASKED FOR A CLINICAL EVALUATION OF THE CASE TO OUR MEDICAL CONSULTANT. FOLLOWING, HIS STATEMENT: "THE UNDERLYING CAUSE OF FAILURE OF THE TSA IS ROTATOR CUFF INSUFFICIENCY, WHICH IS ONE OF THE MAIN LEADING REASONS FOR REVISION OF TSA. IT IS RELATED TO AGE AND OTHER SPECIFIC FACTORS. THE INSUFFICIENT SUPRASPINATUS TENDON IS CLEARLY VISIBLE WHICH LEAD TO THE SUPERIOR MIGRATION. THE GLENOID METALBACK SEEMS TO BE POSITIONED VERY INFERIORLY FOR A TSA, THIS POSITION MIGHT BE OPTIMAL FOR RSA, BUT NOT FOR TSA. THE REASON FOR REVISION THEREFORE IS DISEASE- AND PROCEDURE-RELATED AND NOT IMPLANT-RELATED". BASED ON THE INVESTIGATION PERFORMED, WE CAN CONCLUDE THAT CONTRIBUTORY CAUSES FOR THE FAILURE OF THE SMR ANATOMIC TOTAL PROSTHESIS INVOLVED ARE BOTH PATIENT FACTOR AND SURGICAL FACTOR. EVENT NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMA CORPORATE PMS DATA, WE CAN ESTIMATE A REVISION RATE OF SMR ANATOMIC TOTAL PROSTHESIS DUE TO CUFF FAILURE OF 0,56%. NO SPECIFIC CORRECTIVE ACTIONS FOR THIS CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    CONVERSION FROM SMR ANATOMIC TOTAL TO SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2020 DUE TO CUFF FAILURE. IT WAS REPORTED A DETERIORATION IN PATIENT'S CUFF WITH TIME. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR HUMERAL HEAD Ø52 MM (PRODUCT CODE 1322.09.520, LOT# 0703348 - STER. 1300160) · SMR ECC.ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.278, LOT# 1211492 - STER. 1200341), · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT# 1305943 - STER. 1300229), · LINER F.MET.BACK GLEN.STANDARD (PRODUCT CODE 1377.50.010, LOT# 1308189 - STER. 1300228). ACCORDING TO THE COMPLAINT SOURCE, THE HUMERAL STEM AND THE METAL BACK GLENOID WERE SOLID AND LEFT IN SITU. SURGEON COMMENTED THAT THE PE LINER WAS VERY WORN, AND THE MB WAS SOLID BUT ITS POSTOSUPERIOR LUG WAS WORN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2013. PATIENT IS A MALE, BORN ON (B)(6) 1957. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #0703348, NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THIS LOT #. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON (B)(6) 2020 DUE TO CUFF FAILURE. IT WAS REPORTED A DETERIORATION IN PATIENT'S CUFF WITH TIME. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD 52 MM (PRODUCT CODE 1322.09.520, LOT# 0703348 - STER. 1300160) SMR ECC.ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.278, LOT# 1211492 - STER. 1200341). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT# 1305943 - STER. 1300229). LINER F.MET.BACK GLEN.STANDARD (PRODUCT CODE 1377.50.010, LOT# 1308189 - STER. 1300228). ACCORDING TO THE COMPLAINT SOURCE, THE STEM AND THE METAL BACK WERE SOLID AND LEFT IN SITU. THE IMPLANT WAS CONVERTED TO REVERSE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2013. PATIENT IS A MALE, BORN ON (B)(6). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192377 SMR HUMERAL HEAD 52 MM HUMERAL HEADS (COCRMO) DIA.52MM KWT LIMACORPORATE S.P.A. 1322.09.520 0703348

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention