BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 22-1325 HUMERAL IMPLANT

    MDR report key: 18298577 · Received December 10, 2023

    Report

    Report Number
    3008021110-2023-00137
    Event Type
    Injury
    Date Received
    December 10, 2023
    Date of Event
    November 21, 2023
    Report Date
    November 12, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE DHRS OF THE INVOLVED PRODUCT CODES AND LOT NUMBERS HAVE BEEN CHECKED AS REPORTED IN PREVIOUS COMPLAINT (B)(4), WITHOUT FINDING ANY ANOMALY. SINCE NO COMPONENTS WERE REMOVED DURING THE REVISION HEREBY REPORTED, THE MANUFACTURER DID NOT RECEIVE ANY EXPLANT TO PERFORM FURTHER INVESTIGATION. HOWEVER, THE MANUFACTURER RECEIVED THE RADIOGRAPHIES, TAKEN POST THE (B)(6) 2023, REVISION. THE X-RAYS WERE SENT TO THE MEDICAL EXPERT, WHO COMMENTED AS FOLLOWS: "WE HAVE COMPLEX CASE HERE WITH A BIG BONE DEFICIT AND HISTORY OF INFECTION. THE REASON FOR THE MULTIPLE REVISIONS LIES IN THE HISTORY OF THE CASE, INFECTION RISK IS HIGH ANYWAY, WITH BONE DEFECTS AND THIS STORY THIS IS ALL AN UNFAVORABLE BUT FATEFUL COURSE OF EVENTS. NO SIGN FOR IMPLANT-RELATED FAILURE HERE." HENCE, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THE EVENT - THE RADIOGRAPHIES RECEIVED HAVE BEEN SHARED WITH THE MEDICAL EXPERT, WHO STATED THAT THERE IS NO SIGN OF IMPLANT-RELATED FAILURE. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: NO REVISION RATE IS TO BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. 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

    THE DHRS OF THE INVOLVED PRODUCT CODES AND LOT NUMBERS HAVE BEEN CHECKED AS REPORTED IN PREVIOUS COMPLAINT (B)(4), WITHOUT FINDING ANY ANOMALY. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    AN ELBOW SURGERY WAS PERFORMED ON (B)(6) 2023. DURING A POST-OPERATIVE EVALUATION ON CUSTOM MADE ELBOW DEVICE CMD 22-1325 HUMERAL IMPLANT THE SURGEON NOTICED THE "MOVEMENT"/ LOOSENING OF THE IMPLANTS FROM AN X-RAY DURING A FOLLOW-UP OFFICE VISIT IN LATE OCTOBER 2023. THE REVISION SURGERY TO CORRECT THE LOOSENING OCCURRED ON (B)(6) 2023. THE SURGEON AUGMENTED THE COMPONENT WITH CEMENT AND ADDED THIRD-PARTY PLATING HARDWARE TO SUPPORT THE COMPONENT. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1948, WITH A HISTORY OF MULTIPLE OPERATIONS FOR INFECTED LEFT TOTAL ELBOW ARTHROPLASTY. - SHE UNDERWENT THE FIRST LIMACORPORATE IMPLANTS SURGERY ON (B)(6) 2023, WITH A CUSTOM-MADE DEVICE. DURING THIS SURGERY, THE IMPLANT FELL, AND THE TRIAL WAS FINALLY IMPLANTED. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2023-00115. - THE FOLLOW-UP VISITS IN AUGUST AND SEPTEMBER 2023 DID HIGHLIGHT NO SIGN OF COMPLICATIONS. - DURING THE FOLLOW-UP VISIT ON (B)(6) 2023, THE PATIENT COMPLAINED ULNAR NERVE DISTRIBUTION PAIN AND RADIAL NERVE DISTRIBUTION DECREE SENSATION AND WEAKNESS. THE SURGEON SUGGESTED RADIAL NERVE REPAIR AND RECOMMENDED AUGMENTATION OF THE HUMERAL FIXATION OF THE PROXIMAL FIXATION CONSTRUCT INCLUDING CABLES AND PLATE (THIRD-PARTY PLATING HARDWARE) (HEREBY REPORTED). - THE REVISION SURGERY WAS FINALLY PLANNED ON (B)(6) 2023, FOR RADIAL NERVE REPAIR AND MEDIAL NERVE DECOMPRESSION. AFTER THIS SURGERY, SHE FELT IMPROVEMENT IN HER PAIN AND THE SHOULDER MORE STABLE. - DURING THE FOLLOW-UP VISIT ON (B)(6) 2024, THE PATIENT REPORTED INCREASING PAIN AND FLUID COLLECTION WAS NOTICED. THE SURGEON RECOMMENDED AN IRRIGATION AND DEBRIDEMENT PROCEDURE AND CULTURES. - THE NEXT REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO SUSPECTED INFECTION. A CEMENT PLATE MADE WITH ANTIMICROBIAL CEMENT WAS IMPLANTED. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT 20240157 AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00063. - THE FOLLOW-UP VISIT ON (B)(6) 2024, HIGHLIGHTED PERSISTENT LUCENCY ABOUT THE PROXIMAL PROSTHESIS, POSSIBLE SYMPTOM OF LOOSENING (INFECTION NOT EXCLUDED). - THE NEXT SURGERY WAS PERFORMED ON (B)(6) 2024, DUE TO INFECTION. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00064. EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    AN ELBOW SURGERY WAS PERFORMED ON (B)(6), 2023. DURING A POSTOPERATIVE EVALUATION ON CUSTOM MADE ELBOW DEVICE CMD (B)(6) HUMERAL IMPLANT THE SURGEON NOTICED THE "MOVEMENT"/ LOOSENING OF THE IMPLANTS FROM AN X-RAY DURING A FOLLOW-UP OFFICE VISIT IN LATE (B)(6) 2023. THE REVISION SURGERY TO CORRECT THE LOOSENING OCCURRED ON MONDAY, (B)(6) 2023. SURGEON AUGMENTED THE COMPONENT WITH CEMENT AND ADDED THIRD-PARTY PLATING HARDWARE TO SUPPORT THE COMPONENT. PATIENT - FEMALE. DATE OF BIRTH - (B)(6) 1948. EVENT HAPPENED IN USA. PATIENT HISTORY. HAS LENGTHY HISTORY OF PREVIOUS SURGERIES FOR ELBOW CONDITION. (B)(6), 2023, SURGERY PERFORMED TO IMPLANT LIMA CUSTOM-MADE TOTAL ELBOW PROSTHESIS. AN INTRAOPERATIVE ISSUE OCCURRED. THIS WAS REPORTED ON COMPLAINT (B)(4), NOTIFIED TO THE FDA WITH THE MFR #3008021110-2023-000115 ON (B)(6), 2023. (B)(6), 2023, REVISION SURGERY TO CORRECT "MOVEMENT"/ LOOSENING OF THE IMPLANTS. - OBJECT OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770605 CMD 22-1325 HUMERAL IMPLANT CMD 22-1325 HUMERAL IMPLANT - CUSTOM MADE JDB LIMACORPORATE S.P.A. 9618.15.07V 2313191

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention