BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø42 MM

    MDR report key: 10465224 · Received August 28, 2020

    Report

    Report Number
    3008021110-2020-00063
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    August 21, 2020
    Report Date
    April 2, 2021
    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

    BY CHECKING THE DHR OF THE LOT# 0902784, NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THIS LOT#. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. WE RECEIVED SOME X-RAYS TAKEN ON (B)(6) 2020 THAT UNDERWENT THROUGH A MEDICAL EVALUATION. FOLLOWING, THE STATEMENT RECEIVED FROM OUR MEDICAL CONSULTANT: "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 FACT, THAT THE REVISION WAS NOT PERFORMED AT THE TIME OF ROTATOR CUFF FAILURE LEAD TO THE SUPERIOR MIGRATION, EDGE LOAD OF THE PE LINER AND SUBSEQUENT FAILURE. THE REASON FOR REVISION THEREFORE IS DISEASE-RELATED AND NOT IMPLANT-RELATED". BASED ON THE INVESTIGATION PERFORMED, WE CAN CLASSIFY THIS CASE AS PATIENT FACTOR RELATED. PMS DATA: ESTIMATED REVISION RATE ASSOCIATED TO CUFF FAILURE OF SMR ANATOMIC TOTAL PROSTHESIS IS (B)(4). NONE OF THE CASE INVESTIGATED HAVE BEEN CLASSIFIED AS PRODUCT RELATED. 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 MDR.

    Description of Event or Problem · 0

    CONVERSION FROM SMR ANATOMIC TOTAL PROSTHESIS TO SMR REVERSE PROSTHESIS DUE TO CUFF FAILURE PERFORMED ON (B)(6) 2020. DURING SURGERY, THE SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT #0902784 - STER.(B)(4)) WAS EXPLANTED. IT WAS REPORTED THAT THE SURGEON NOTED SUPERIOR WEAR OF THE GLENOID PE LINER AND GLENOID METAL BACK PROSTHESIS TO THE LEVEL OF SUPERIOR SCREW. ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT ROTATOR CUFF GRADUALLY DETERIORATED OVER TIME: THE PATIENT ONLY RECENTLY DECIDED TO CONVERT THE PROSTHESIS TO A REVERSE DUE TO THE PRESENCE OF A NOT AESTHETICALLY PLEASING HUMERAL GEYSER, DESPITE THAT IN 2017 WAS OFFERED A CONVERSION BY THE SURGEON. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2009. PATIENT CLINICAL DATA: FEMALE, BORN ON (B)(6)1935, 156 CM HIGH, WEIGHT 46 KG. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT# 0902784, NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THIS LOT#. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO CUFF FAILURE PERFORMED ON (B)(6) 2020. DURING SURGERY THE SMR HUMERAL HEAD 42 MM (PRODUCT CODE 1322.09.420, LOT #0902784 - STER.0900224) WAS EXPLANTED. THE IMPLANT WAS CONVERTED TO A REVERSE. IT WAS REPORTED THAT THE SURGEON NOTED SUPERIOR WEAR OF THE GLENOID PE LINER AND GLENOID METAL BACK PROSTHESIS TO THE LEVEL OF SUPERIOR SCREW. ACCORDING TO THE COMPLAINT SOURCE, THE PATIENT ROTATOR CUFF GRADUALLY DETERIORATED OVER TIME: THE PATIENT ONLY RECENTLY DECIDED TO CONVERT THE PROSTHESIS TO A REVERSE DUE TO THE PRESENCE OF A NOT AESTHETICALLY PLEASING HUMERAL GEYSER, DESPITE THAT IN 2017 WAS OFFERED A CONVERSION BY THE SURGEON. PREVIOUS SURGERY PERFORMED ON (B)(6) 2009. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933252 SMR HUMERAL HEAD Ø42 MM HUMERAL HEADS (COCRMO) DIA.42MM KWT LIMACORPORATE S.P.A. 1322.09.420 0902784

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention