BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø44 MM

    MDR report key: 14468425 · Received May 23, 2022

    Report

    Report Number
    3008021110-2022-00043
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    May 5, 2022
    Report Date
    September 27, 2022
    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 #1817490, NO ANOMALIES WERE FOUND ON THE ITEMS MANUFACTURED WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON LOT #1817490. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT NUMBER 1817490, NO ANOMALIES WERE FOUND ON THE ITEMS MANUFACTURED WITH THE SAME LOT NUMBER. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON LOT NUMBER 1817490. ACCORDING TO OUR RECORDS, AT LEAST 52 OUT OF 68 SMR HUMERAL HEADS WITH LOT NUMBER 1817490 AND STER. 1800388 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. EXPLANTS ANALYSIS AND FURTHER INFORMATION THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. FURTHER INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, IN PARTICULAR: THE DATE OF THE THREE X-RAYS SHARED CLINICAL DATA OF THE PATIENT. THE COMPLAINT SOURCE REPORTED THAT THE X-RAYS ARE PRE-OPERATIVE, TAKEN BEFORE THE REVISION SURGERY. HOWEVER, THE EXACT DATE IN WHICH THEY ARE TAKEN IN NOT KNOWN. IN ADDITION, THERE WERE NO OTHER CLINICAL DATA OF THE PATIENT AVAILABLE, WITH THE EXCEPTION FOR THE BMI (25). X-RAYS ANALYSIS: THE X-RAYS PROVIDED WERE SENT TO THE MEDICAL EXPERT, WHO STATED THAT "THE INITIAL RADIOGRAPH SHOWS THE ATTEMPT FOR REFIXATION OF THE TUBEROSITIES TO THE PROSTHESIS WHICH FAILED TO INCORPORATE A HEAL IN THE LONG RUN. THIS PHENOMENON IS WELL DESCRIBED IN THE LITERATURE AND HAPPENS QUITE OFTEN. THE SUBSEQUENT INSTABILITY IS DUE TO THE FAILED ROTATOR CUFF FUNCTION BECAUSE THE CUFF LOSES ITS ATTACHMENT TO THE HUMERUS AND CANNOT WORK ANYMORE. THERE IS NO IMPLANT-RELATED FAILURE HERE, THIS IS A FATEFUL CAUSE OF EVENTS, THAT IS RELATED TO THE UNDERLYING CONDITION". IN CONCLUSION: THE CHECK OF THE DHR HIGHLIGHTS NO PRE-EXISTING ANOMALIES ON THE SMR HUMERAL HEAD LOT NUMBER 1817490 ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE SURGEON CHOSE TO DO AN ANATOMICAL TSR FOR TRAUMA INSTEAD OF GOING STRAIGHT TO A REVERSE TOTAL ARTHROPLASTY ACCORDING TO THE OPINION OF THE MEDICAL EXPERT, THE EVENT IS RELATED TO THE UNDERLYING CONDITION (ATTEMPT FOR REFIXATION OF THE TUBEROSITIES AND ROTATOR CUFF FAILURE). WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, WE ESTIMATE A REVISION RATE OF SMR HUMERAL HEADS (BELONGING TO PRODUCT CODES 1322.09.XXX) DUE TO DISLOCATION TO BE 0,07%. NO SPECIFIC CORRECTIVE ACTION IS NEEDED FOR THIS 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 IMPLANT PERFORMED ON (B)(6) 2022, DUE TO DISLOCATION. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022, AND IT WAS REPORTED THAT THE SURGEON CHOSE TO DO AN ANATOMICAL TSR FOR TRAUMA INSTEAD OF GOING STRAIGHT TO A REVERSE TOTAL ARTHROPLASTY. ACCORDING TO THE REPORTED INFORMATION, THE TUBEROSITIES WERE DISRUPTED AND FRACTURED AFTER A SHORT PERIOD OF TIME RESULTING IN THE DISLOCATION OF THE JOINT. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE 1322.09.440, LOT #1817490 - STER. 1800388). NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #1712462 - STER. 1700386). SMR TRAUMA HUMERAL BODY # MEDIUM (PRODUCT CODE 1350.15.010, LOT #1916227 - STER. 1900380). LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT #20AT3K4 - STER. 2100083). A 44MM CORRECTION GLENOSPHERE, SHORT REVERSE BODY AND SHORT LINER WERE IMPLANTED. PATIENT IS A FEMALE, (B)(6) YEARS OLD. EVENT HAPPENED IN (B)(6)..

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6)2022, DUE TO DISLOCATION OF SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE 1322.09.440, LOT NUMBER 1817490 - STER. 1800388). PREVIOUS SURGERY TOOK PLACE ON (B)(6)2022, AND IT WAS REPORTED THAT THE SURGEON CHOSE TO DO AN ANATOMICAL TSR FOR TRAUMA INSTEAD OF GOING STRAIGHT TO A REVERSE TOTAL ARTHROPLASTY. ACCORDING TO THE REPORTED INFORMATION, THE TUBEROSITIES WERE DISRUPTED AND FRACTURED AFTER A SHORT PERIOD OF TIME RESULTING IN THE DISLOCATION OF THE JOINT. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE 1322.09.440, LOT NUMBER 1817490 - STER. 1800388) · NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT NUMBER 1712462 - STER. 1700386) · SMR TRAUMA HUMERAL BODY # MEDIUM (PRODUCT CODE 1350.15.010, LOT NUMBER 1916227 - STER. 1900380) · LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT NUMBER 20AT3K4 - STER. 2100083) A 44MM CORRECTION GLENOSPHERE, SHORT REVERSE BODY AND SHORT LINER WERE IMPLANTED. PATIENT IS A FEMALE, 81 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618263 SMR HUMERAL HEAD Ø44 MM HUMERAL HEADS (COCRMO) DIA.44MM KWT LIMACORPORATE S.P.A. 1322.09.440 1817490

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention