Integrity Implant 6000101Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00817337000258), received between Dec 3, 2024 and Aug 17, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expulsion” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  An adverse event was reported from an Integrity PMCF study involving the shoulder. The subject reported continued stiffness and limited motion in the operated shoulder, and a glenohumeral injection was performed. The event began on (b)(6) 2026 and was ongoing at the time of reporting, with no end date available. Symptoms were mild, the event was not serious, and no serious health threat was reported. The safety event was classified as an adverse event, device classification was not applicable, causality was assessed as possible/uncertain, and the outcome was reported as resolving. This case will updated with any new relevant information.

  Patient problems: Limb Pain; Loss of Range of Motion

  MAUDE report 50273620 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  A post-market clinical follow-up notification was reported for a patient with a right shoulder retear following surgically repaired rotator cuff repair using an Integrity patch. The event was ongoing at the time of reporting, described as mild, not serious, and classified as an adverse event/adverse device effect with a reported definite causal relationship; the outcome was unknown. The patient received a steroid injection at the 6-month follow-up visit to help treat the new tear and continued physical therapy. Additional information indicated that baseline and 6-month postoperative MRI images were provided, the product was not available for return, the clinician was very experienced with use of the device, and there was no indication of mal-implantation. Symptoms were reported to have appeared approximately 185 days after device implantation. Follow-up notes indicated that at 6 weeks post right shoulder rotator cuff repair the patient remained sore, was prescribed anti-inflammatory medication, had the sling removed, and was directed to begin physical therapy. At the 6-month follow-up, the patient reported significant right shoulder pain without recalled trauma, ongoing discomfort

  Patient problems: Inadequate Pain Relief; Limb Pain; Loss of Range of Motion

  MAUDE report 50155134 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  A DISTRIBUTOR REPORTED THE FOLLOWING TO ANIKA: THE PRODUCT INVOLVED IS THE INTEGRITY IMPLANT, INDICATED FOR ACHILLES TENDON REPAIR. THE PROCEDURE WAS PERFORMED ON (B)(6) 2026 ON A FEMALE PATIENT AGED OVER 60 YEARS OLD, WITH NO HISTORY OF DIABETES AND AN ACTIVE LIFESTYLE. THE IMPLANT USED MEASURED 25MM X 30MM, WITH LOT NUMBER 000012728 AND EXPIRY DATE OF 28 JULY 2028. THE PATIENT WAS DIAGNOSED WITH A MID-SUBSTANCE ACHILLES TENDON TEAR CONFIRMED VIA MRI. SURGICAL INTERVENTION INVOLVED ACHILLES TENDON REPAIR WITH SUTURE AND INTEGRITY AUGMENTATION, UTILIZING VICRYL PLUS 4-0 SUTURES. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. POSTOPERATIVELY, THE PATIENT DEVELOPED COMPLICATIONS. ON (B)(6) 2026, THE WOUND WAS OBSERVED TO HAVE PARTIAL GAPING. BETWEEN (B)(6) 2026, THE WOUND WAS DEBRIDED AND SUBSEQUENTLY CLOSED. HOWEVER, IN (B)(6) 2026, FOLLOWING STO, THE WOUND REMAINED GAPING. AN INFECTION WAS OBSERVED SEVERAL WEEKS AFTER THE INITIAL SURGERY, WHICH ULTIMATELY NECESSITATED THE REMOVAL OF THE INTEGRITY AUGMENTATION. THIS EVENT HAS BEEN CLASSIFIED AS A POSTOPERATIVE WOUND COMPLICATION WITH ASSOCIATED INFECTION." PRODUCT: INTEGRITY IMPLANT, INDICATION USED: ACHILLES TENDON REPAIR, REPORT T

  Patient problems: Post Operative Wound Infection

  MAUDE report 25430695 ↗
• InjuryApr 6, 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 13MAR2026 OUR COMMERCIAL MANAGER WAS NOTIFIED BY A DOCTOR STATING THAT HE PERFORMED A ROTATOR CUFF REPAIR ON A 54-YEAR-OLD FEMALE PATIENT ON (B)(6) 2026 USING AN ANIKA 25X30MM INTEGRITY IMPLANT PN 6000101 LN 0000012728 UTILIZING AN INTEGRITY IMPLANT FIXATION KIT PN 6000102 LOT: 75AE1142. ON (B)(6) 2026 THE DOCTOR STATED THAT HE BELIEVES THE INTEGRITY IMPLANT CAUSED AN INFLAMMATORY RESPONSE AND EXTREME SWELLING IN THE PATIENT'S SHOULDER. THE PATIENT HAD TO BE RETURNED TO THE OR FOR THE GRAFT TO BE REMOVED AND RESOLVE THE PATIENT'S INFLAMMATORY RESPONSE. THE DOCTOR STATED THIS LOOKS LIKE AN EXTREME BODILY RESPONSE TO THE GRAFT AND TOWARDS THE ANTERIOR PORTAL IN THE PATIENT'S SHOULDER. DOCTOR ALSO TOLD THE COMMERCIAL MANAGER THAT HE GOT CULTURES OF THIS PATIENT TO SEE IF IT WAS INFECTION THAT WAS CAUSING THIS PROBLEM AND LAB CULTURES CAME BACK AS NEGATIVE FOR INFECTION. UPON R

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 24793007 ↗
• MalfunctionMar 10, 2025Expulsion; Expulsion

  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 ON THIS REPORT. ON 12FEB2025 IT WAS REPORTED TO ANIKA THAT THE PATIENT OF UNKNOWN AGE AND DEMOGRAPHICS DIDN'T HEAL AND HAD A SMALL POST OP WOUND AND IT WAS REPORTED THAT A PART OF THE INTEGRITY PATCH WAS COMING OUT OF THE WOUND. THE PATIENT RECEIVED A REVISION PROCEDURE AND IS REPORTEDLY HEALING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21562164 ↗
• InjuryDec 3, 2024Expulsion; Expulsion

  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 ON THIS REPORT. ON 08 NOVEMBER 2024 IT WAS REPORTED TO ANIKA THAT THE HEALTHCARE PROVIDER (HPC) IMPLANTED AN INTEGRITY PATCH ON A 44-YEAR-OLD PATIENT ON (B)(6) 2024 ON THE FOOT/ANKLE. THE PATIENT WAS SEEN BY THE HCP ON (B)(6) 2024 FOR FOLLOW UP. THERE IS NO REPORT OF ANY PATIENT IMPACT DURING THIS VISIT. ON OR ABOUT (B)(6) 2024 THE HCP STATED THAT THE PATIENT BEGAN TO EXPERIENCE WHAT IS REPORTED TO BE A REACTION TO THE INTEGRITY PATCH. THE PATIENT REPORTED WHAT APPEARED TO BE A "ZIT" AND UPON SQUEEZING IT, A PART OF THE PATCH CAME OUT OF THE ENCLOSURE SITE. THE PATIENT WAS CULTURED ON (B)(6) 2024 (RESULT OF THE CLOSURE WAS NEGATIVE). THE REMOVAL OF THE REST OF THE INTEGRITY PATCH WAS SCHEDULED TO OCCUR ON OR ABOUT (B)(6) 2024 SINCE THE PATIENT IS STARTING TO SHOW SIGNS OF ANOTHER STERILE PUSTULE WHERE THE PIECE OF THE INTEGRITY IMPLANT. THE RESULT OF THE PROCEDURE HAS NOT BEEN PROVIDED AT THIS

  Patient problems: Fluid Discharge; Foreign Body Reaction

  MAUDE report 20833552 ↗