BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANT

    MDR report key: 24474401 · Received February 27, 2026

    Report

    Report Number
    1221934-2026-00905
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    August 16, 2024
    Report Date
    February 27, 2026
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: D1, D4, G1, G4 (510K), H4: THIS REPORT IS FOR AN UNKNOWN AIR POWERED HANDPIECE DEVICE. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE EXPIRATION DATE, UDI NUMBER, 510-K NUMBER, MANUFACTURING SITE NAME, AND DEVICE MANUFACTURE DATE ARE UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 0

    THIS IS REPORT 2 OF 3 OF (B)(4) THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: NADEAU NJ, MARDER RS, FASULO SM, RICHARDS SM, KRAEUTLER MJ, SCILLIA AJ. COMPARABLE PAIN LEVELS AND FUNCTIONAL OUTCOMES WITH AND WITHOUT THE USE OF DERMAL ALLOGRAFT AUGMENTATION IN ENDOSCOPIC GLUTEUS MEDIUS REPAIR. ARTHROSCOPY. 2025 JUN;41(6):1799-1805. DOI: 10.1016/J.ARTHRO.2024.08.024. EPUB 2024 AUG 30. PMID: 39209076. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO COMPARE RETROSPECTIVELY THE CLINICAL OUTCOMES OF PATIENTS UNDERGOING ENDOSCOPIC GLUTEAL TENDON REPAIR WITH AND WITHOUT THE USE OF DERMAL ALLOGRAFT AUGMENTATION. BETWEEN APRIL 2017 AND APRIL 2022, ALL PATIENTS UNDERWENT ENDOSCOPIC GLUTEUS MEDIUS REPAIR (26 GMR PATIENTS) USING (HEALIX ADVANCE; DEPUY SYNTHES, RAYNHAM, MA) AND GMR WITH AUGMENTATION (38 GMR-A PATIENTS) USING DERMAL ALLOGRAFTS (DERMIS ON DEMAND, DEPUY SYNTHES). THE MEAN FOLLOW-UP PERIOD IN GMR: (39.4 26.9) AND GMR-A (24.2 11.7) LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: HEALIX ADVANCE; DEPUY SYNTHES, RAYNHAM, MA AND DERMIS ON DEMAND, DEPUY SYNTHES. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT: HEALIX ADVANCE (QTY 1) N=1 (GMR GROUP); UNDERWENT REVISION GMR WITH DERMAL ALLOGRAFT AUGMENTATION, DUE TO RE-TEAR OF THE GLUTEUS MEDIUS TENDON AND RECURRENCE OF PAIN. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT: HEALIX ADVANCE (QTY 1) N=1 (GMR-A GROUP); UNDERWENT REVISION GMR WITH DERMAL ALLOGRAFT AUGMENTATION, DUE TO RE-TEAR OF THE GLUTEUS MEDIUS TENDON AND RECURRENCE OF PAIN. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT: DERMIS ON DEMAND (QTY 1) N=1 (GMR-A GROUP); UNDERWENT REVISION GMR WITH DERMAL ALLOGRAFT AUGMENTATION, DUE TO RE-TEAR OF THE GLUTEUS MEDIUS TENDON AND RECURRENCE OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530182 UNK - IMPLANT SOFT-TISSUE ANCHOR, BIOABSORBABLE MIA DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention