Integrity Implant 6000100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817337000241), received between Jan 5, 2026 and Jan 28, 2026 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  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 TH

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24202448 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  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 16DEC2025, THE FOLLOWING WAS REPORTED TO ANIKA: PATIENT SURGERY WAS PERFORMED ON A 54-YEAR-OLD MALE ON (B)(6) 2025 FOR A ROTATOR CUFF REPAIR OF SUPRASPINATUS TENDON USING AN INTEGRITY IMPLANT ANIKA PN 6000100 25MMX30MM LOT NUMBER 0000012194. NO RADIOGRAPHS TAKEN IMMEDIATELY AFTER IMPLANT SURGERY. NO INFECTION DUE TO IMPLANT. PRODUCT NOT AVAILABLE FOR RETURN. NO APPARENT MALFUNCTION. NO DELAY IN PROCEDURE. SUCCESSFUL ROTATOR CUFF REPAIR WAS COMPLETED. ON (B)(6) 2025, THE PATIENT FELT INCREASED PAIN DURING PHYSICAL THERAPY. ULTRASOUND SHOWS CONCERN FOR AREA OF NONHEALING OR RECURRENT TEAR, MRI ORDERED. ON (B)(6) 2025 THE FOLLOWING ADDITIONAL INFORMATION WAS REPORTED FROM PRIMARY CLINICAL SPECIALIST FOR SURGEON: AN MRI WAS COMPLETED ON (B)(6) 2025. THE MRI DID NOT SHOW A RETEAR OF THE ROTATOR CUFF REPAIR. IT IS BELIEVED THE ADVERSE EVENT WAS LIKELY DUE TO POOR COMPLIANCE AND M

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23961382 ↗