BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY IMPLANT

    MDR report key: 24202448 · Received January 28, 2026

    Report

    Report Number
    3007093114-2026-00002
    Event Type
    Injury
    Date Received
    January 28, 2026
    Date of Event
    January 1, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ANIKA THERAPEUTICS, INC.
    Product Code
    OWX
    UDI-DI
    00817337000241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. FOLLOW-UP: A PATIENT UNDERWENT ROTATOR CUFF REPAIR AND LATER RETURNED WITH INCREASED SHOULDER PAIN AND CREPITUS; ULTRASOUND FINDINGS WERE CONSISTENT WITH TENDINOPATHY AND A SUBACROMIAL INJECTION WAS ADMINISTERED. NO DEVICE MALFUNCTION, PROCEDURAL DELAY, INFECTION, EXPLANT, OR DEVICE RETURN WAS REPORTED, AND THE IMPLANT WAS NOT SUSPECTED TO HAVE BEEN PLACED INCORRECTLY. MANUFACTURING REVIEW OF THE IMPLICATED LOT FOUND THE PRODUCT MET SPECIFICATIONS AND WAS MANUFACTURED AND RELEASED PER APPLICABLE PROCEDURES; ANY DOCUMENTED REWORK WAS UNRELATED TO THE COMPLAINT. A THREE-YEAR RETROSPECTIVE REVIEW OF NONCONFORMANCE RECORDS AND RECORD-RETENTION INSPECTION LOGS FOUND NO ISSUES RELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE REVIEWED AND WERE CONSIDERED TO SUFFICIENTLY ADDRESS WARNINGS, STORAGE/HANDLING PRECAUTIONS, AND DEVICE-SPECIFIC INFORMATION. AN INTERNAL CLINICAL TRIALS REVIEW DID NOT PROVIDE ADDITIONAL INFORMATION, AND A CLINICAL ASSESSMENT NOTED A TEMPORAL ASSOCIATION BETWEEN THE SYMPTOMS AND PRODUCT USE, THOUGH THE COMPLAINT COULD NOT BE CONFIRMED AND NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED. THE EVENT WILL CONTINUE TO BE MONITORED AND TRENDED FOR FUTURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED IN THIS REPORT. ON 13JAN2025, THE FOLLOWING WAS REPORTED TO ANIKA: COMPLAINANT BECAME AWARE 25DEC2025 OF A 57-YEAR-OLD MALE PATIENT RETURNING WITH CREPITANCE AND ONGOING PAIN 57 DAYS AFTER A ROTATOR CUFF REPAIR USING AN INTEGRITY IMPLANT ANIKA PN 6000100 25MMX30MM LOT NUMBER 0000012194. PT OFFERED SUBACROMIAL INJECTION AS TENDON WAS DOUBLE IN SIZE ON ULTRASOUND. PT COMORBIDITIES UNKNOWN. NO INDICATION THAT THE INTEGRITY HA-BASED COMPOSITE IMPLANT IMPLANTED INCORRECTLY. DEVICE NOT EXPLANTED. NO INFECTION DUE TO THE IMPLANT. ON (B)(6) 2026, THE CLINICAL MANAGER REPORTED THE FOLLOWING ADDITIONAL INFORMATION TO ANIKA: PATIENT'S COMORBIDITIES ARE HYPERTENSION. POST TREATMENT PROTOCOLS PROVIDED TO THE PATIENT. POST SURGICAL EXPECTATIONS AND PROTOCOLS WERE DISCUSSED AND PROVIDED IN PRINT TO THE PATIENT. PROTOCOLS ARE BEING FOLLOWED. FORMAL PHYSICAL THERAPY WAS INITIATED APPROXIMATELY 3 WEEKS FROM THE DATE OF THE PROCEDURE. SUBJECT IS STILL ACTIVE IN THE STUDY. PATIENT DISCHARGE SUMMARY NOT PROVIDED. NO DELAY IN THE PROCEDURE. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION IS BEING SOLICITED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED IN THIS REPORT. ON 13JAN2025, THE FOLLOWING WAS REPORTED TO ANIKA: COMPLAINANT BECAME AWARE (B)(6) 2025 OF A 57-YEAR-OLD MALE PATIENT RETURNING WITH CREPITANCE AND ONGOING PAIN 57 DAYS AFTER A ROTATOR CUFF REPAIR USING AN INTEGRITY IMPLANT ANIKA PN 6000100 25MMX30MM LOT NUMBER 0000012194. PT OFFERED SUBACROMIAL INJECTION AS TENDON WAS DOUBLE IN SIZE ON ULTRASOUND. PT COMORBIDITIES UNKNOWN. NO INDICATION THAT THE INTEGRITY HA-BASED COMPOSITE IMPLANT IMPLANTED INCORRECTLY. DEVICE NOT EXPLANTED. NO INFECTION DUE TO THE IMPLANT. ON (B)(6) 2026, THE CLINICAL MANAGER REPORTED THE FOLLOWING ADDITIONAL INFORMATION TO ANIKA: PATIENT'S COMORBIDITIES ARE HYPERTENSION. POST TREATMENT PROTOCOLS PROVIDED TO THE PATIENT. POST SURGICAL EXPECTATIONS AND PROTOCOLS WERE DISCUSSED AND PROVIDED IN PRINT TO THE PATIENT. PROTOCOLS ARE BEING FOLLOWED. FORMAL PHYSICAL THERAPY WAS INITIATED APPROXIMATELY 3 WEEKS FROM THE DATE OF THE PROCEDURE. SUBJECT IS STILL ACTIVE IN THE STUDY. PATIENT DISCHARGE SUMMARY NOT PROVIDED. NO DELAY IN THE PROCEDURE. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION IS BEING SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371665 INTEGRITY IMPLANT MESH, SURGICAL, NON-ABSORBABLE, ORTHOPAEDICS, REINFORCEMENT OF TENDON OWX ANIKA THERAPEUTICS, INC. 0000012194 00817337000241

    Patients

    Seq Age Sex Outcome Treatment
    1