ATTUNE 1517-10-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295055815), received between Aug 7, 2020 and Apr 13, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN ATTUNE REVISION TKA WHICH WAS EXTREMELY STIFF. SURGEON STATES THAT IN THE TKA REVISION PROCEDURE, THE PATELLAR TENDON HAD BEEN DAMAGED AT THE TIBIAL INSERTION, CAUSING THE PREVIOUS SURGEON TO RESTRICT MOTION POST- OPERATIVELY. SURGEON AND FELLOW REMOVED ALL THE RESIDUAL SCAR TISSUE AND REMOVED THE 10MM POLY REPLACING THE POLY WITH A 6MM POLY. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; Unspecified Tissue Injury

  MAUDE report 24861224 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT I&D FOR THE KNEE AND WAS ALSO IMPLANTED WITH LARGER SIZE INSERT FOR STABILITY. DOI (B)(6) 2025, DOR (B)(6) 2025, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23575955 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SECOND LINER EXCHANGE TO RULE OUT INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23488261 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LINER EXCHANGE TO RULE OUT INFECTION. DURING THE REVISION, THE IMPLANT PATELLA FELL RIGHT OFF. IT WAS LOOSE AT THE IMPLANT CEMENT INTERFACE. IT WAS NOT REPLACED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23466152 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S POLY WAS SWAPPED DUE TO FEAR OF INFECTION. PATIENT WAS CULTURE NEGATIVE AND POLY WAS EXCHANGED. NOTHING FURTHER TO REPORT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20577439 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LINER EXCHANGE. DOWNSIZED INSERT TO DUE FLEXION TIGHTNESS. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 19163734 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING TO RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018 DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE) TREATMENT: DIAGNOSTIC INTERVENTION

  Patient problems: Swelling/ Edema

  MAUDE report 18928765 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CHIEF COMPLAINT WAS PAIN. THE SURGEON WENT IN WITH THE THOUGHT THE PATIENT HAD AN INFECTED RTK. THE COMPONENTS IN PLACE WAS AN ATTUNE REVISION TOTAL KNEE COMPONENTS. THE SURGEON REMOVED THE INSERT IN PLACE TO INCREASE EXPOSURE. IT WAS A 4X10MM CRS RP INSERT. AFTER RECEIVING A PATHOLOGY REPORT STATING NO INFECTION, ALL OF THE OTHER COMPONENTS WERE INSPECTED AND APPEARED TO BE WELL FIXED AND IN GOOD POSITION SO ALL OTHER COMPONENTS WERE RETAINED. AFTER AN IRRIGATION AND DEBRIDEMENT (I&D) WAS PREFORMED A NEW INSERT WAS CHOSEN AND THEN CLOSED IN THE USUAL FASHION. DOI: (B)(6) 2018; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18857675 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18587792 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT A POLY SWAP FOR POSSIBLE INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17715265 ↗
• InjuryJan 4, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA WITH UNK IMPLANTS. IT IS ALSO UNKNOWN WHETHER THE IMPLANTS USED PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. AFTER THE PRIMARY SURGERY, INFECTION WAS OCCURRED. THE REVISION SURGERY WAS DONE WITH ATTUNE REVISION IMPLANTS ON (B)(6) 2022. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE INSERT IN QUESTION SPUN OUT DURING REHABILITATION. A REVISION SURGERY WILL BE PERFORMED SOON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16095111 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO STIFFNESS AND LIMITED ROM. THE INSERT WAS DOWNSIZED. THERE WAS NO LOOSENING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 14238403 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION WAS COMPLETED TO ADDRESS SOFT TISSUE LAXITY. POLY WAS CHANGED FROM A 10MM TO A 16MM. DOI : (B)(6) 2021. DOR : (B)(6) 2021. RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 13196369 ↗
• InjuryDec 20, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT DESCRIBED FELT A POP AND SPIN. SURGEON WENT IN THE 4X10 CRS POLY WAS SPUN SIDEWAYS. SURGEON PERFORMED A POLY SWAP AND UPSIZED POLY TO INCREASE STABILITY. SURGEON THEN TRIALED AND WENT FROM A 4X10 TO A 4X16. A 4X16 WAS FINALLY IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 13043652 ↗
• InjuryMay 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE 4X10 RPS POLY WAS BROKEN AND NEEDED TO BE REVISED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, UNKNOWN AFFECTED SIDE.

  Patient problems: Insufficient Information

  MAUDE report 11856117 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE SURGEON DID A WASHOUT AND INSERT EXCHANGE. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11133702 ↗
• InjuryDec 7, 2020Adverse 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 REVISION KNEE. THE PATIENT'S ARTHROTOMY HAS SPLIT OPEN, SO THE SURGEON DID A LINER EXCHANGE AND REPAIRED THE ARTHROTOMY. ALL COMPONENTS ARE WELL FIXED AND RETAINED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 10958768 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS ARE WELL-FIXED. THE SURGEON DID A WASHOUT AND AN INSERT EXCHANGE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10391919 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10378967 ↗