BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR SHOULDER

    MDR report key: 20307683 · Received September 26, 2024

    Report

    Report Number
    3008021110-2024-00081
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    January 31, 2025
    Report Date
    October 6, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    K142139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED, NO PRE-EXISTING ANOMALY WAS DISCOVERED ON THE ITEMS MANUFACTURED WITH THE SAME LOT NUMBERS. WE WOULD LIKE TO POINT OUT THAT DURING THE REVISION PERFORMED ON (B)(6) 2024, THE FOLLOWING COMPONENTS HAVE BEEN IMPLANTED: - SMR CEMENTL. REV. STEM Ø14 MM (PART CODE 1308.15.144). - FINNED REVERSE HUM. BODY 140° (PART CODE 1352.15.051). - SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.811). - SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314). - SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE 1376.09.041). AMONG THOSE PARTS, THE COMBINATIONS BETWEEN THE FOLLOWING COMPONENTS ARE CONSIDERED OFF-LABEL: - 140 HUMERAL BODY (PART NUMBER 1352.15.051) AND REVERSE LINER (PART NUMBER 1365.50.811). - CONNECTOR LAT +4 (PART NUMBER 1374.15.314) AND 40MM ECC GLENOSPHERE (PART NUMBER 1376.09.041). WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    UPCOMING RIGHT SHOULDER REVISION SURGERY, DUE TO DISLOCATION. THE PATIENT PRESENTED WITH A DISLOCATION ON (B)(6) 2024. SURGEON HAD PREVIOUSLY DISCUSSED WITH THE PATIENT THAT THERE IS NOTHING MORE THAT CAN BE DONE AS THE GLENOID SIDE IS LATERALIZED TO THE MAXIMUM. LASTLY, A CTA HEMIARTHROPLASTY PROSTHESIS WOULD NOT PROVIDE ADEQUATE FUNCTION. SURGEON HAS THEREFORE REQUESTED LIMACORPORATE CUSTOM RETENTIVE HUMERAL LINERS AND SMR REVERSE HP GLENOSPHERES TO STABILIZE THE CURRENT ARTHROPLASTY. THE COMPONENTS CURRENTLY IMPLANTED ARE THE FOLLOWING: - SMR CEMENTL. REV. STEM Ø14 MM (PART CODE 1308.15.144, LOT NUMBER 1314748, STERILIZATION 2000364) - FINNED REVERSE HUM. BODY 140° (PART CODE 1352.15.051, LOT NUMBER 2014680, STERILIZATION 2100020) - SMR REVERSE LINER RETENTIVE (PART CODE 1365.50.811, LOT NUMBER 19AT1AV, STERILIZATION 1900324) - SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314, LOT NUMBER 2329796, STERILIZATION 2400002) - SMR ECCENT. GLENOSPHERE Ø 40MM (PART CODE 1376.09.041, LOT NUMBER 2226888, STERILIZATION 2200311) THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1959. THE PATIENT UNDERWENT A SMR REVERSE RIGHT TOTAL SHOULDER ARTHROPLASTY IN (B)(6) 2023 TO ADDRESS A MALUNION OF A PROXIMAL HUMERUS FRACTURE SUSTAINED IN (B)(6) 2021. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT DID WELL UNTIL (B)(6) 2024, WHEN SHE FELL ON HER NEWLY CLEANED KITCHEN FLOOR, SUSTAINING A DISPLACED PERIPROSTHETIC PROXIMAL HUMERUS FRACTURE. THIS WAS TREATED ON (B)(6) 2024, WITH A NEW SET OF LIMACORPORATE SMR COMPONENTS (LONG REVISION STEM, HUMERAL BODY, +9MM HUMERAL BODY EXTENSION, +6MM LATERALIZED 40MM DIAMETER HUMERAL LINER, AND +4MM LATERALIZED 40MM DIAMETER GLENOSPHERE) AND THIRD-PARTY METAL CERCLAGE FIXATION CABLES. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4). MULTIPLE INTRAOPERATIVE TESTS SHOWED THE PROSTHESIS TO HAVE EXCELLENT STABILITY. HOWEVER, THE PATIENT EXPERIENCED RECURRENT, ATRAUMATIC DISLOCATIONS AND REQUIRED FOLLOW-UP OPERATIONS WITH LIMA SMR COMPONENTS. IN THE FIRST INCIDENT, THE PATIENT PRESENTED WITH A DISLOCATION ON (B)(6) 2024 AND WAS REVISED ON (B)(6) 2024. DURING THIS REVISION, THE GLENOSPHERE WAS REPLACED WITH A +4MM LATERALIZED 40MM DIAMETER ECCENTRIC GLENOSPHERE, AND A NEW SET OF HUMERAL COMPONENTS WERE IMPLANTED. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00079. IN THE SECOND INCIDENT, THE PATIENT PRESENTED WITH A DISLOCATION ON MAY 9TH, 2024, AND WAS REVISED ON JUNE 28TH, 2024. ON JUNE 12TH, THE PATIENT WAS NOTED TO HAVE A QUESTIONABLE INFECTION, BUT PHYSICAL EXAMINATION OF THE SUTURES SHOWED NO SIGNS OF DEEP INFECTION. DURING THIS REVISION, A NEW GLENOSPHERE IDENTICAL TO THE ONE PLACED ON APRIL 26TH, 2024, WAS IMPLANTED. ON THE HUMERAL SIDE, A NEW SET OF COMPONENTS WERE PLACED, INCLUDING A RETENTIVE HUMERAL LINER. NO SIGNS OF INFECTION WERE NOTED INTRAOPERATIVELY. EXTENSIVE IRRIGATION AND DEBRIDEMENT WAS DONE PRIOR TO PLACEMENT OF THE COMPONENTS. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT 20240189 AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00080. IN THE THIRD INCIDENT, THE PATIENT PRESENTED WITH A DISLOCATION ON JULY 10TH, 2024. THE SURGEON HAD PREVIOUSLY DISCUSSED WITH THE PATIENT THAT THERE IS NOTHING MORE THAT CAN BE DONE AS THE GLENOID SIDE IS LATERALIZED TO THE MAXIMUM. THE SURGEON HAS DETERMINED THAT A FUNCTIONING, STABLE REVERSE ARTHROPLASTY CANNOT BE ACHIEVED WITH COMMERCIALLY AVAILABLE LIMACORPORATE GLENOSPHERE/HUMERAL LINER OPTIONS. THE SURGEON HAS THEREFORE REQUESTED LIMACORPORATE CUSTOM RETENTIVE HUMERAL LINERS AND SMR REVERSE HP GLENOSPHERES TO STABILIZE THE CURRENT ARTHROPLASTY (EVENT HEREBY REPORTED). EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243361 SMR SHOULDER REVERSE RETENTIVE LINER 40MM STANDARD PHX LIMACORPORATE S.P.A. 1365.50.811 19AT1AV

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention