BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø48 MM

    MDR report key: 16252799 · Received January 27, 2023

    Report

    Report Number
    3008021110-2023-00004
    Event Type
    Injury
    Date Received
    January 27, 2023
    Date of Event
    January 13, 2023
    Report Date
    April 28, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    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 #1102660, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 79 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 68 OUT OF 79 HUMERAL HEADS WITH LOT #1102660 - STER. 1100248 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. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED 4 CT SCANS AND A COUPLE OF X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE CT SCANS AND X-RAYS RECEIVED - ALL DATED 20/09/2022 - AND ONE PICTURE OF THE GLENOID LINER EXPLANTED ON (B)(6) 2023, HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS ON THE FIRST REVISION SURGERY: "THE FIRST REVISION IS DUE TO ANTERO-SUPERIOR ESCAPE OF THE HUMERAL HEAD WHICH ITSELF IS DUE TO ROTATOR CUFF FAILURE. THE EXPLANT IS UNREMARKABLE. THIS IS A FATEFUL COURSE OF EVENTS, NO IMPLANT RELATED ISSUES APPARENT". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1102660; · ACCORDING TO THE RECEIVED INFORMATION, THE EVENT MIGHT BE RELATED TO A ROTATOR CUFF TEAR; · ACCORDING TO THE MEDICAL CONSULTANT, "THE FIRST REVISION IS DUE TO ANTERO-SUPERIOR ESCAPE OF THE HUMERAL HEAD WHICH ITSELF IS DUE TO ROTATOR CUFF FAILURE. THE EXPLANT IS UNREMARKABLE"; WE CAN STATE THAT THE EVENT WAS PATIENT RELATED. THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR HUMERAL HEADS - BELONGING TO THE FAMILY CODES 1322.09.XXX - DUE TO DISLOCATION IS 0.07%. 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.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1102660, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 79 ITEMS MANUFACTURED WITH THE SAME LOT #. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL IMPLANT PERFORMED ON (B)(6) 2023, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT THE EVENT MIGHT BE RELATED TO A ROTATOR CUFF TEAR. THE ANATOMIC COMPONENTS WERE REMOVED: · SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE 1322.09.480, LOT #1102660 - STER. 1100248). · SMR ECCENTRIC ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.278, LOT #1005535 - STER. 1000204). · SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #1103047 - STER. 110024 9). · LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.51.070, LOT #1109029 - STER. 1100274) - PRODUCT NOT SOLD IN THE US. THE PROSTHESIS WAS CONVERTED TO REVERSE CONFIGURATION. PATIENT IS A MALE. NO CLINICAL INFORMATION IS AVAILABLE. HIS HISTORY OF SHOULDER SURGERIES IS THE FOLLOWING: - PRIMARY IMPLANT PERFORMED ON (B)(6) 2011; - FIRST REVISION SURGERY ON (B)(6) 2023, DUE TO DISLOCATION (HEREBY REPORTED); - SECOND REVISION SURGERY ON (B)(6) 2023, DUE TO DISLOCATION (EVENT REGISTERED AS COMPLAINT #046_23). DURING IT, THE REVERSE HP LINER IMPLANTED ON (B)(6) 2023, WAS EXPLANTED AND REPLACED BY A LATERALIZING ONE. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL IMPLANT PERFORMED ON (B)(6) 2023, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT THE EVENT MIGHT BE RELATED TO A ROTATOR CUFF TEAR. THE ANATOMIC COMPONENTS WERE REMOVED: SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE 1322.09.480, LOT #1102660 - STER. 1100248). SMR ECCENTRIC ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.278, LOT #1005535 - STER. 1000204). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #1103047 - STER. 110024 9). LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.51.070, LOT #1109029 - STER. 1100274) - PRODUCT NOT SOLD IN THE US. THE PROSTHESIS WAS CONVERTED TO REVERSE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2011. PATIENT IS A MALE. NO CLINICAL INFORMATION IS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617427 SMR HUMERAL HEAD Ø48 MM HUMERAL HEADS (COCRMO) DIA.48MM KWT LIMACORPORATE S.P.A. 1322.09.480 1102660

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention