ATTUNE 1516-50-707Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295052722), received between Feb 2, 2018 and Feb 17, 2026 — classified as 77 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A CYST IN SOFT TISSUE MEDIAL AND POSTERIOR IN KNEE. COMMUNICATED WITH A CYST IN BONE. CYST WAS DRAINED AND TIBIA WAS REVISED. NO ALLEGATION AGAINST IMPLANTS; IMPLANTS WERE NOT LOOSE. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Cyst(s)

  MAUDE report 24367671 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PAINFUL KNEE. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24326667 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HYPERTROPHIC BONE FORMATION OVER THE PATELLA. THE SURGEON SWAPPED THE POLY WHEN OPENED THE PATIENT'S KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 24129257 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN/INSTABILITY. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23535654 ↗
• InjurySep 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED DUE TO INFLAMMATION. ALL PIECES WERE REMOVED FROM THE FIELD AND DISPOSED OF BY THE HOSPITAL, THERE WAS NO HARM DONE TO THE PATIENT NOR DELAY TO THE. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Inflammation

  MAUDE report 23018009 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR POLY SWAP AND IRRIGATION AND DEBRIDEMENT IN THE RIGHT KNEE. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 22518491 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SURGICAL SITE INFECTION. DOI: UNKNOWN. DOR: (B)(6), 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22367175 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR SUSPECTED INFECTION. THE SURGEON OPTED FOR A POLY SWAP AND INCREASED IN THICKNESS. THERE WAS NO KNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22299387 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POPLITIAL INJURY FOLLOWED BY A HEMATOGENOUS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22284185 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL KNEE DONE BY THE SURGEON. THE KNEE IS INFECTED AND THE SURGEON DID A WASHOUT WITH THE TIBIAL INSERT EXCHANGE. ONLY THE TIBIAL INSERT WAS REVISED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22183555 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A RIGHT TOTAL ATTUNE KNEE. THE PATIENT HAD SOME SORT OF EVENT THAT CAUSED HIM TO STRETCH OUT HIS MCL. THE SURGEON REVISED HIS TIBIAL INSERT AND TIGHTENED DOWN HIS MCL. ALL OTHER COMPONENTS ARE WELL FIXED AND RETAINED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22174716 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: B. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO. C. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO.

  Patient problems: Unspecified Infection

  MAUDE report 21208631 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS REMOVED AND EXCHANGED AS PATIENT WAS EXPERIENCING SOME PAIN. THERE WAS NO NOTICEABLE WEAR. TIBIAL IMPLANT WAS NOT LOOSE. IMPLANTS WERE WELL FIXED AND POLY WAS UPSIZED ONE MILLIMETER IN FOLLOW UP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20836562 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN MRSA INFECTION. THE KNEE WAS WASHED OUT, AND THE POLY WAS REMOVED AND REPLACED WITH A NEW ONE OF THE SAME SIZE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20086880 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19940159 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PULLED OUT THE FEMUR/POLY/TIBIA/AND PATELLA DUE TO INFECTION. CLEANED OUT THE INFECTED AREA AND CHIPPED AWAY ALL OF THE OLD CEMENT. SURGEON THEN USED ANTIBIOTIC BEADS/CEMENT/A PS FEMUR/AND A CRS POLY AS AN ANTIBIOTIC SPACER TO RID OF THE INFECTION BEFORE THE PATIENT RECEIVES A FULL ATTUNE REVISION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19540723 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19061613 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION WASHOUT PERFORMED . DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18659681 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND WASHOUT PERFORMED. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 18659556 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY SWAPPED DUE TO INFECTION. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17890270 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17564252 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. I&D POLY EXCHANGE TOOK PLACE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17333016 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO LOOSENING REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17265661 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16974034 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR LIGAMENT INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16843684 ↗