BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALIX ADVANCE

    MDR report key: 25301070 · Received May 27, 2026

    Report

    Report Number
    1221934-2026-02211
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    December 17, 2025
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MAI
    UDI-DI
    10886705030590
    PMA / PMN Number
    K191242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: THE COMPLAINT DEVICE WAS NOT RETURNED TO DEPUY SYNTHES, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (116L683), AND THERE WAS NO NON-CONFORMANCE WAS IDENTIFIED. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    SUBJECT ID: (B)(6). STUDY NO: (B)(6). POST MARKET COMPLICATION RECEIVED FOR RE-TEARS OR NEW TEARS (LEFT KNEE DISPLACED BUCKET HANDLE MEDIAL MENISCUS TEAR). DATE OF EVENT: (B)(6) 2025. DATE OF IMPLANT: (B)(6) 2023 (LEFT ACL TEAR, MEDIAL MENISCUS TEAR, LATERAL MENISCUS TEAR). DATE OF REOPERATION/REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RE-OPERATION WITH NO IMPLANT REMOVED/IMPLANTED DEPUY SYNTHES PRODUCTS USED: RGDLOOP ADJUSTABLE LONG: CATALOG NUMBER: 232448. LOT NUMBER: 8L67308. DEPUY SYNTHES PRODUCTS USED: TRUESPAN 12 DEGREE PEEK: CATALOG NUMBER: 228151. LOT NUMBER: 9L71051. DEPUY SYNTHES PRODUCTS USED: INTRAFIX ADVANCE 10X23 SCREW & LARGE 23MM SHEATH. CATALOG NUMBER: 254803. LOT NUMBER: 9L62950. DEPUY SYNTHES PRODUCTS USED: 5.5MM HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR. CATALOG NUMBER:222424. LOT NUMBER: 116L683. REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266217 HEALIX ADVANCE FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI MEDOS INTERNATIONAL SàRL 116L683 10886705030590

    Patients

    Seq Age Sex Outcome Treatment
    1