BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOABSORBABLE INTERFERENCE SCREWS

    MDR report key: 21208270 · Received January 22, 2025

    Report

    Report Number
    3004549189-2025-00001
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    June 15, 2022
    Report Date
    January 22, 2025
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2025. OTHER MEDICAL DEVICES NOT MANUFACTURED BY SBM WERE USED DURING THIS SURGERY. THE REVISION PROCEDURE OCCURRED AT (B)(6) MEDICAL CENTER: (B)(6) USA. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - VERIFICATION OF MANUFACTURING DATA: MANUFACTURE OF 195 PRODUCTS IN DECEMBER 2019 - NO INCIDENTS DURING MANUFACTURING - THE RESULTS OF ONGOING CONTROLS ARE COMPLIANT - VERIFICATION OF THE STERILIZATION DATA OF THE PRODUCTS OF THIS LOT: IRRADIATION DOSES ARE IN LINE WITH EXPECTED SPECIFICATIONS. VERIFICATION OF MANUFACTURING DATA REVEALED NO ANOMALIES. EVERYTHING CONFORMS TO EXPECTED SPECIFICATIONS. THE RESULTS OF THE INVESTIGATIONS DO NOT LINK THE DEVICE TO THE CAUSE OF THE REPORTED EVENT. NO ACTION IMPLEMENTED. THE IRRADIATION CERTIFICATE FOR THE BATCH CONCERNED HAS BEEN FORWARDED TO OUR DISTRIBUTOR.

    Description of Event or Problem · 0

    FNCONF-25-0014. INCIDENT OCCURED IN USA. EVENT DESCRIPTION COMMUNICATED BY OUR DISTRIBUTOR. "ON MONDAY, DECEMBER 30, 2024, LEGAL RECEIVED THE FOLLOWING NEW CLAIM. NO ADDITIONAL INFORMATION IS AVAILABLE. THE ATTACHED USAGE SHEET SHOWS THAT AN SBM SCREW WAS INVOLVED IN THE EVENT". PATIENT: PPN. IMPLANT DATE: (B)(6) 2022. IMPLANT SURGEON: DR. (B)(6). IMPLANT FACILITY: (B)(6) CENTER. SUMMARIZATION FROM THE SUMMONS ATTACHMENTS: PATIENT HAD A MENISCAL TEAR IN HIS RIGHT KNEE AROUND 2015 (SURGICALLY REPAIRED). IN 2021, PATIENT STARTED HAVING RIGHT KNEE PAIN AND SOUGHT TREATMENT THROUGH AN ORTHOPEDIST. PATIENT WAS DIAGNOSED WITH LIGAMENT RUPTURE & MENISCAL TEAR IN HIS RIGHT KNEE AND REFERRED TO DR. (B)(6) FOR KNEE TREATMENT. ON (B)(6) 2022, PATIENT UNDERWENT RIGHT KNEE ARTHROSCOPY TO REPAIR LIGAMENT AND MENISCUS AND IMPLANT ZIMMER BIOMET PRODUCTS. IMMEDIATELY AFTER, PATIENT BEGAN EXPERIENCING SEVERE PAIN AND LACK OF MOBILITY. PATIENT COULD NOT REACH DR. (B)(6) AND SOUGHT HELP AT (B)(6) HOSPITAL ON (B)(6) 2022. PATIENT WAS SUFFERING FROM CHILLS, NIGHT SWEATS, FEVER AND SEVERE RIGHT KNEE PAIN. PATIENT WAS DISCHARGED ON (B)(6), BUT PATIENT'S PAIN INCREASED UNTIL UNABLE TO MOVE IN SEPTEMBER AND PATIENT HAD TO CALL 911. PATIENT WAS TAKEN TO (B)(6) HOSPITAL. DUE TO THE EXTENT OF THE PATIENT'S PAIN AND SEVERE DAMAGE TO THE KNEE JOINT, DR. (B)(6) PERFORMED EMERGENCY SURGERY ON (B)(6) 2022, REMOVING THE ACL GRAFT AND HARDWARE. A BIOPSY PERFORMED DURING THE SURGERY DIAGNOSED THE PATIENT WITH FUNGAL SEPTIC ARTHRITIS. AN ADDITIONAL OPERATION WAS PERFORMED ON (B)(6) 2022 TO REMOVE FUNGAL GROWTH AND CLEAN THE KNEE. PATIENT CONTINUED TO EXPERIENCE PAIN AND REMAINED IN THE HOSPITAL UNTIL (B)(6) 2022 WITH A NERVE BLOCK FOR HIS KNEE PAIN. THE CLAIM STATES THE PATIENT CONTINUES TO SUFFER EXTREME PAIN AND IS WORKING WITH HIS DOCTORS TO KILL THE FUNGAL INFECTION AND RESTORE SOME FUNCTIONALITY TO THE JOINT, BUT HIS PROGNOSIS IS DIRE. PATIENT WILL LIKELY NEVER WALK UNASSISTED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681512 BIOABSORBABLE INTERFERENCE SCREWS COMPOSITCP60 RESORBABLE INTERFERENCE SCREW - Ø11MM L30MM MAI S.B.M. SAS 195056

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other| R