BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø50 MM

    MDR report key: 19143177 · Received April 19, 2024

    Report

    Report Number
    3008021110-2024-00037
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 19, 2024
    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

    CHECKING THE MANUFACTURING CHARTS OF INVOLVED LOT #1011536, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE 40 DEVICES MANUFACTURED WITH THAT LOT #. ACCORDING TO OUR RECORDS, AT LEAST 37 OUT OF 40 HUMERAL HEADS WITH LOT #1011536 AND STER. 1100190 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS EXPLANTED COMPONENTS WERE NOT RETURNED TO LIMACORPORATE FOR INVESTIGATION. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE NOT ACCESSIBLE. BASED ON THE FEW INFORMATION RECEIVED WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT, HOWEVER CONSIDERING THAT: · CHECK OF MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON COMPONENTS MANUFACTURED WITH LOT #1011536; · THE CUFF FAILED APPROXIMATELY 18 MONTHS PREVIOUS TO THE REVISION SURGERY, CONTRIBUTING TO THE OBSERVED EROSION OF THE LINER, AND TO THE PRESENCE OF METALLOSIS AS A RESULT OF THE METAL ON METAL; · THERE WAS PRESENCE OF A PSEUDOTUMOR IN THE SHOULDER JOINT; · THE SURVIVORSHIP OF THE PROSTHESIS WAS OF 12 YEARS; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED, RATHER IT WAS DUE TO THE PATIENT'S CONDITION. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF SMR ANATOMIC PROSTHESIS (TOTAL AND HEMI) DUE TO CUFF FAILURE IS 0.54%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2024, DUE TO CUFF FAILURE. IT WAS REPORTED THAT THE CUFF FAILED APPROXIMATELY 18 MONTHS AGO. ACCORDING TO THE RECEIVED INFORMATION, THERE WAS EROSION OF THE SUPERIOR PORTION OF THE LINER IN POLYETHYLENE, LIKELY TO HAVE BEEN CAUSED BY THE CUFF FAILURE, AND THERE WAS MODERATE METALLOSIS AS A RESULT OF THE METAL ON METAL. THERE WAS AS WELL THE PRESENCE OF A PSEUDOTUMOR IN AND AROUND SHOULDER ARTICULATION SURFACES THAT WAS REMOVED. THE WHOLE AREA WAS DEBRIDED THOROUGH. THE IMPLANT WAS CONVERTED TO REVERSE CONFIGURATION. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR HUMERAL HEAD Ø50 MM (PRODUCT CODE 1322.09.500, LOT #1011536 - STER. 1100190) · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #1108248 - STER. 1100493) · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #1105291 - STER. 1100290) · LINER FOR METALBACK GLENOID SMALL (PRODUCT CODE 1377.51.060, LOT #1106405 - STER. 1100160) PRIMARY SURGERY TOOK PLACE ON (B)(6) 2012. PATIENT IS A FEMALE, 78 YEARS OLD. NO OTHER CLINICAL INFORMATION IS AVAILABLE. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686633 SMR HUMERAL HEAD Ø50 MM HUMERAL HEADS (COCRMO) DIA.50MM KWT LIMACORPORATE S.P.A. 1322.09.500 1011536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention