BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMA ELBOW

    MDR report key: 15823725 · Received November 18, 2022

    Report

    Report Number
    3008021110-2022-00115
    Event Type
    Injury
    Date Received
    November 18, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 4, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    UDI-DI
    08033390140089
    PMA / PMN Number
    K222807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING CHARTS WERE CHECKED WITH THE FOLLOWING RESULTS: NO PRE-EXISTING ANOMALY WAS FOUND ON THE 21 ITEMS, BELONGING TO PRODUCT CODE 1550.15.900, LOT NUMBER 1814381 AND STERILIZATION NUMBER 1900179. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 3 ITEMS, BELONGING TO PRODUCT CODE 1552.14.021, LOT NUMBER 1811310, STERILIZATION NUMBER 1900181. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 21 ITEMS, BELONGING TO PRODUCT CODE 1560.50.021, LOT NUMBER 18AT1RV, STERILIZATION NUMBER 1900225. NO PRE-EXISTING ANOMALY WAS FOUND ON THE 16 ITEMS, BELONGING TO PRODUCT CODE 1575.14.010, LOT NUMBER 2001330, STERILIZATION NUMBER 2000092. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE MANUFACTURING CHARTS WERE CHECKED WITH THE FOLLOWING RESULTS: - NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4) ITEMS, BELONGING TO PRODUCT CODE 1550.15.900, LOT NUMBER 1814381 AND STERILIZATION NUMBER (B)(4). - NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4) ITEMS, BELONGING TO PRODUCT CODE 1552.14.021, LOT NUMBER 1811310, STERILIZATION NUMBER (B)(4). - NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4) ITEMS, BELONGING TO PRODUCT CODE 1560.50.021, LOT NUMBER 18AT1RV, STERILIZATION NUMBER (B)(4). - NO PRE-EXISTING ANOMALY WAS FOUND ON THE (B)(4) ITEMS, BELONGING TO PRODUCT CODE 1575.14.010, LOT NUMBER 2001330, STERILIZATION NUMBER (B)(4). THE COMPONENTS REMOVED WERE NOT AVAILABLE TO BE RETURNED FOR FURTHER INSPECTION. HOWEVER, WE RECEIVED MORE DETAILS ABOUT THE INITIAL SURGERY. ACCORDING TO THE INFORMATION SHARED BY THE COMPLAINT SOURCE, DURING THE SURGERY PERFORMED ON (B)(6) 2022, "A CEMENT RESTRICTOR WAS PLACED INTO THE HUMERUS. THE CEMENT WAS MIXED AND INSERTED INTO THE HUMERUS AND ULNA. THE CUSTOM SIZE 12 HUMERAL IMPLANT WAS INSERTED. THE SIZE 5 ULNA WAS INSERTED. ONCE THE CEMENT DRIED, THE COMPONENTS WERE LINKED WITH THE AXLE AND TORQUE LIMITING SCREWDRIVER. FINAL FLUOROSCOPIC IMAGING DEMONSTRATED EXCELLENT ALIGNMENT. THE ELBOW TRACKED SMOOTHLY". IT SHOULD BE NOTED THAT, ACCORDING TO THE CASE REPORT OF THE CMD 21-1412, THE HUMERAL STEM FORESEES AN UNCEMENTED FIXATION. HOWEVER, THE SURGEON DECIDED TO INSERT CEMENT INTO THE HUMERUS AND ULNA, EVEN IF THE MANUFACTURER'S INSTRUCTIONS INDICATE UNCEMENTED FIXATION OF THE HUMERAL STEM. FURTHERMORE, WE RECEIVED THE PRE-OPERATIVE RADIOGRAPHIES, AND WE SHARED THEM WITH OUR MEDICAL EXPERT, WHO STATED THAT "THE KEY LIES IN THE PATIENT HISTORY. PRIOR INFECTION AND RADIATION THERAPY ARE THE MOST PROBABLE CAUSE OF LOOSENING. I CANNOT SEE ANY IMPLANT RELATED ISSUES." HENCE, ACCORDING TO THE INFORMATION GATHERED: - NO PRE-EXISTING ANOMALIES HAVE BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THE EVENT. - IN THE MEDICAL EXPERT'S OPINION, PRIOR INFECTION AND RADIATION THERAPY ARE THE MOST PROBABLE CAUSE OF LOOSENING, AND THERE IS NO SIGN OF IMPLANT RELATED ISSUES. - IT SHOULD BE CONSIDERED THAT THE PATIENT HAD A METASTATIC LESION TO THE RIGHT HUMERUS, AND ACCORDING TO THE TEMA ELBOW IFU, ONE OF THE RISK FACTORS THAT MAY LEAD TO A POOR RESULT WITH THIS PROSTHESIS IS THE PRESENCE OF LOCAL OR DISSEMINATED NEOPLASTIC DISEASES. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO OUR RECORDS, WE HAVE REGISTERED 4 COMPLAINTS FOR LOOSENING WHICH HAVE INVOLVED AN ULNAR BODY TEMA ELBOW BELONGING TO THE FAMILY PRODUCT CODE 1552.14.XXX AND, AMONG THE COMPLAINTS REGISTERED ABOVE MENTIONED, THIS IS THE ONLY REVISION SURGERY DUE TO ASEPTIC LOOSENING. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTION IS REQUIRED FOR THIS SPECIFIC 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

    ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INSTABILITY AND LOOSENING. PATIENT PRESENTED WITH INCREASED INSTABILITY. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS WERE EXPLANTED: HUMERAL SAFETY SCREW HUM.BODY (PRODUCT CODE 1550.15.900, LOT NUMBER 1814381, STERILIZATION NUMBER 1900179). ULNAR BODY LARGE RIGHT + SCREW (PRODUCT CODE 1552.14.021, LOT NUMBER 1811310, STERILIZATION NUMBER 1900181). ULNAR LINER - LARGE RIGHT (PRODUCT CODE 1560.50.021, LOT NUMBER 18AT1RV, STERILIZATION NUMBER 1900225). ULNAR STEM #U5 (PRODUCT CODE 1575.14.010, LOT NUMBER 2001330, STERILIZATION NUMBER 2000092). THE ULNAR COMPONENT WAS DISLODGED FROM THE ULNA. HUMERAL COMPONENT WAS NOT EXPLANTED AND THERE ARE NO SIGNS OF INFECTION. SURGERY WAS COMPLETED AND ULNAR IMPLANT WAS REMOVED. SEVERAL CULTURES WERE TAKEN DURING THE SURGERY BUT THERE IS NO MENTION OF INFECTION. PATIENT'S CLINICAL HISTORY: EXTENSIVE SURGICAL HISTORY ON THE RIGHT ELBOW. HE HAD A METASTATIC LESION TO THE RIGHT HUMERUS (RENAL CELL CARCINOMA) WITH PATHOLOGIC FRACTURE THAT WENT ON TO NON-UNION AND SUBSEQUENTLY WAS TREATED WITH A FREE FIBULA VASCULARIZED GRAFT, FOLLOWED BY EXTERNAL FIXATOR, AND DEBRIDEMENT PROCEDURES FOR RESULTANT INFECTION. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT WAS A MALE, 59 YEARS OLD. EVENT HAPPENED IN UNITED STATES.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INSTABILITY AND LOOSENING. PATIENT PRESENTED WITH INCREASED INSTABILITY. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS WERE REMOVED: - HUMERAL SAFETY SCREW HUM.BODY (PRODUCT CODE 1550.15.900, LOT NUMBER 1814381, STERILIZATION NUMBER (B)(4)). - ULNAR BODY LARGE RIGHT + SCREW (PRODUCT CODE 1552.14.021, LOT NUMBER 1811310, STERILIZATION NUMBER (B)(4)). - ULNAR LINER - LARGE RIGHT (PRODUCT CODE 1560.50.021, LOT NUMBER 18AT1RV, STERILIZATION NUMBER (B)(4)). - ULNAR STEM #U5 (PRODUCT CODE 1575.14.010, LOT NUMBER 2001330, STERILIZATION NUMBER (B)(4)). THE ULNAR COMPONENT WAS DISLODGED FROM THE ULNA. HUMERAL COMPONENT (CUSTOM MADE DEVICE CMD 21-1412) WAS NOT REMOVED AND THERE ARE NO SIGNS OF INFECTION. SURGERY WAS COMPLETED AND ULNAR IMPLANT WAS REMOVED, WITHOUT IMPLANTING ANY NEW DEVICE. SEVERAL CULTURES WERE TAKEN DURING THE SURGERY BUT THERE WAS NO MENTION OF INFECTION. THE PATIENT HAD THE FOLLOWING CLINICAL HISTORY: EXTENSIVE SURGICAL HISTORY ON THE RIGHT ELBOW. HE HAD A METASTATIC LESION TO THE RIGHT HUMERUS (RENAL CELL CARCINOMA) WITH PATHOLOGIC FRACTURE THAT WENT ON TO NON-UNION AND SUBSEQUENTLY WAS TREATED WITH A FREE FIBULA VASCULARIZED GRAFT, FOLLOWED BY EXTERNAL FIXATOR, AND DEBRIDEMENT PROCEDURES FOR RESULTANT INFECTION. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. DURING THIS SURGERY, THE SURGEON NOTED THAT GIVEN PRIOR HISTORY OF RADIATION TO THE AREA INVOLVED AS WELL AS NUMEROUS SURGICAL PROCEDURES, THERE WAS ABUNDANT SCAR AND FIBROTIC TISSUE MAKING THE DISSECTION MUCH MORE CHALLENGING AND TIME CONSUMING. PATIENT WAS A MALE, 59 YEARS OLD. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230909 TEMA ELBOW ULNAR BODY LARGE RIGHT JDC LIMACORPORATE S.P.A. 1552.14.021 1811310 08033390140089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention