BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREWS

    MDR report key: 24444031 · Received February 25, 2026

    Report

    Report Number
    3008021110-2026-00155
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 30, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBF
    UDI-DI
    08033390106795
    PMA / PMN Number
    K191746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHRS) AND STERILIZATION CHARTS FOR THE INVOLVED LOT NUMBERS WERE REVIEWED, AND NO PRE EXISTING ANOMALIES WERE IDENTIFIED. THE COMPLAINT SOURCE PROVIDED SEVERAL X RAYS AND SUPPORTING DOCUMENTS, INCLUDING OPERATIVE NOTES AND MICROBIOLOGICAL TEST RESULTS. ALL AVAILABLE DOCUMENTATION WAS FORWARDED TO A MEDICAL EXPERT FOR EVALUATION. THE EXPERT STATED: "THE CASE IS A CLEAR INFECTION PROBLEM WITH SEPTIC LOOSENING. THE RADIOGRAPHS SHOW SEVERE BONE EROSION IN THE EARLY YEARS AROUND THE STEM AT THE PROXIMAL HUMERUS. ALTHOUGH THIS CAN HAVE OTHER REASONS, MOST OF THE TIME IT IS RELATED TO THE INFECTION. IN THE END THE SAMPLE TAKEN ON 09TH FEBRUARY 2026 IDENTIFIED CUTIBACTERIUM ACNES AND CONFIRMED INFECTION. THERE IS NO SIGN FOR IMPLANT RELATED FAILURE. IT IS A FATEFUL COURSE OF EVENTS." BASED ON THE INFORMATION REVIEWED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT: · THE DHR REVIEW DID NOT REVEAL ANY PRE EXISTING ANOMALIES. · THE MEDICAL EXPERT CONFIRMED THE REPORTED INFECTION AND FOUND NO INDICATION OF IMPLANT RELATED FAILURE. WE CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA ACCORDING TO OUR PMS DATA, THE REVISION RATE FOR INFECTION ASSOCIATED WITH SMR REVERSE IMPLANTS IS APPROXIMATELY 0.067%. CMD 22 1070 IS A UNIQUE DEVICE MANUFACTURED FOR A SPECIFIC PATIENT; THEREFORE, NO INDICATIVE REVISION RATE CAN BE CALCULATED. THIS IS A FINAL MDR REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHRS) AND STERILIZATION CHARTS FOR THE LOT NUMBERS INVOLVED HAVE BEEN REVIEWED; NO PRE EXISTING ANOMALIES WERE IDENTIFIED. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2026. THE EXACT REASON FOR REVISION IS NOT CLEAR, BUT POSSIBLE INFECTION WAS REPORTED. NO NEW IMPLANTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATIENT HAS A GIRDLESTONE SITUATION. PREVIOUS SURGERY PERFORMED ON (B)(6) 2022. FOLLOWING THE DEVICES EXPLANTED: CMD 22-1070 GLENOID IMPLANT (PRODUCT CODE: 9618140HC, LOT: 2209828 - STER: 2200121). SMR REVERSE HP LINER SHORT (PRODUCT CODE:136209010, LOT:2024152 - STER: 2100088). SMR REVERSE HUMERAL BODY (PRODUCT CODE:135220010, LOT: 2204557 - STER: 2200095). CORTIC.BONE SCREW D.4,5 L.26MM (PRODUCT CODE: 843115026, LOT: 2008183 - STER: 2000219). SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE:137450440, LOT: 2205022 - STER: 2200081). CORTIC.BONE SCREW D.4,5 L.32MM (PRODUCT CODE: 843115032, LOT: 1918239 - STER: 1900386). CORTIC.BONE SCREW D.4,5 L.28MM (PRODUCT CODE: 843115028, LOT: 2110540 - STER: 2100384). PATIENT MALE, 65 YEARS OLD, BMI 26.87. EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2026. THE EXACT REASON FOR REVISION IS NOT CLEAR, BUT POSSIBLE INFECTION WAS REPORTED. NO NEW IMPLANTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATIENT HAS A GIRDLESTONE SITUATION. PREVIOUS SURGERY PERFORMED ON (B)(6) 2022. FOLLOWING THE DEVICES EXPLANTED: CMD 22-1070 GLENOID IMPLANT (PRODUCT CODE: 9618140HC, LOT: 2209828 - STER: (B)(4) , SMR REVERSE HP LINER SHORT (PRODUCT CODE:136209010, LOT:2024152 - STER: (B)(4), SMR REVERSE HUMERAL BODY (PRODUCT CODE:135220010, LOT: 2204557 - STER: (B)(4), CORTIC.BONE SCREW D.4,5 L.26MM (PRODUCT CODE: 843115026, LOT: 2008183 - STER: (B)(4), SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE:137450440, LOT: 2205022 - STER: (B)(4), CORTIC.BONE SCREW D.4,5 L.32MM (PRODUCT CODE: 843115032, LOT: 1918239 - STER: (B)(4), CORTIC.BONE SCREW D.4,5 L.28MM (PRODUCT CODE: 843115028, LOT: 2110540 - STER: (B)(4). PATIENT MALE, 65 YEARS OLD, BMI 26.87. EVENT OCCURRED IN GERMANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624664 BONE SCREWS CORTICAL BONE SCREW - FLATTENED HEAD DIA. 4,5 MM L 26 MM MBF LIMACORPORATE S.P.A. 8431.15.026 2008183 08033390106795

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Other