BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - IMPLANT

    MDR report key: 25200854 · Received May 18, 2026

    Report

    Report Number
    1221934-2026-02065
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    December 30, 2025
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED, AND NO CONCLUSION CAN BE DRAWN AT THIS TIME. E1. REPORTER INFORMATION: (B)(6). (B)(6), HOSPITAL (B)(6). (B)(6), (B)(6) HOSPITAL (B)(6). (B)(6), (B)(6) HOSPITAL, (B)(6).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ZHOU P, WEN Z, WANG H, ZHAO M, LI S, ZHANG P. SUPRAPECTORAL BICEPS TENODESIS ACHIEVES BETTER SHORT CLINICAL OUTCOMES THAN LABRAL REPAIR FOR TYPE V SLAP LESIONS IN ACTIVE-DUTY MILITARY PATIENTS WITH SHOULDER INSTABILITY AFTER BANKART REPAIR. BMC SURG. 2025 DEC 30;26(1):93. DOI: 10.1186/S12893-025-03475-7. PMID: 41469623; PMCID: PMC12860162. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO COMPARE THE OUTCOMES OF ARTHROSCOPIC BANKART REPAIR COMBINED WITH ARTHROSCOPIC SLAP REPAIR AND ARTHROSCOPIC BANKART REPAIR COMBINED WITH SUPRAPECTORAL BICEPS TENODESIS IN ACTIVE-DUTY MILITARY INDIVIDUALS WITH TYPE V SLAP LESIONS. BETWEEN JUNE 2015 TO APRIL 2022, A TOTAL OF 70 PATIENTS (MEAN AGE OF 25.50 ± 7.47 - 31.36 ± 6.06) WITH SHOULDER JOINT INSTABILITY WHO UNDERWENT BANKART REPAIR SURGERY SIMULTANEOUSLY WITH ARTHROSCOPIC SLAP REPAIR (REPAIR GROUP) USING 2¿3 ABSORBABLE SUTURE ANCHORS (3.0 MM GRYPHON BR, DEPUY MITEK INC., SWITZERLAND) AND ARTHROSCOPIC BANKART REPAIR COMBINED WITH SUPRAPECTORAL BICEPS TENODESIS (TENODESIS GROUP) USING 2.0-MM SUTURES (ORTHOCORD®; DEPUY SYNTHES, WEST CHESTER, PA, USA) AND 4.9-MM KNOTLESS SUTURE ANCHOR (VERSALOK®; DEPUY SYNTHES). FOR ALL PATIENTS, THE SHORTEST FOLLOW-UP PERIOD WAS 24 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 2¿3 ABSORBABLE SUTURE ANCHORS (3.0 MM GRYPHON BR, DEPUY MITEK INC., SWITZERLAND), 2.0-MM SUTURES (ORTHOCORD®; DEPUY SYNTHES, WEST CHESTER, PA, USA) AND 4.9-MM KNOTLESS SUTURE ANCHOR (VERSALOK®; DEPUY SYNTHES). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT ORTHOCORD (QTY 6). N=4; BICEPS BRACHII IRRITATION SYMPTOMS - WITH REST AND ORAL NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, ALL FOUR PATIENTS ACHIEVED COMPLETE RESOLUTION OF SYMPTOMS WITHIN SIX WEEKS POSTOPERATIVELY. N=1; RESIDUAL PAIN - NO INTERVENTION REPORTED. N=1; FIXATION FAILURE (ANCHOR LOOSENING) - NO INTERVENTION REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT VERSALOK (QTY 6). N=4; BICEPS BRACHII IRRITATION SYMPTOMS - WITH REST AND ORAL NONSTEROIDAL ANTI-INFLAMMATORY DRUGS, ALL FOUR PATIENTS ACHIEVED COMPLETE RESOLUTION OF SYMPTOMS WITHIN SIX WEEKS POSTOPERATIVELY. N=1; RESIDUAL PAIN - NO INTERVENTION REPORTED. N=1; FIXATION FAILURE (ANCHOR LOOSENING) - NO INTERVENTION REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT GRYPHON BR (QTY 10). N=4; SHOULDER INSTABILITY DUE TO POSTOPERATIVE RETRAUMATIZATION, WHICH REQUIRED REVISION SURGERY WITH SUPRAPECTORAL BICEPS TENODESIS. N=5; COULD NOT PERFORM HORIZONTAL BAR PULL-UP EXERCISES OR THROWING EXERCISES BECAUSE OF LIMITED SHOULDER FLEXION - NO INTERVENTION REPORTED. N=1; RESIDUAL PAIN - NO INTERVENTION REPORTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - IMPLANT GRYPHON BR (QTY 1). N=1; FIXATION FAILURE (ANCHOR LOOSENING) - NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297990 UNK - IMPLANT SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1