ATTUNE 1516-30-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295047773), received between May 30, 2018 and Feb 23, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS NO ALLEGATION AGAINST IMPLANT. PATIENT COMPLAINED A PAIN. SURGEON DID A SOFT TISSUE RELEASE AND EXCHANGE POLYETHYLENE SINCE IT WAS INSIDE THE JOINT CAPSULE. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24419826 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STIFFNESS WITH LIMITED MOTION OF THE RIGHT TOTAL ATTUNE KNEE. THE SURGEON DID A DEBRIDEMENT AND WAS ABLE TO ACHIEVE FULL MOTION. THE TIBIAL INSERT WAS EXCHANGED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17509270 ↗
• InjuryMar 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL IN PACU AND DISLOCATED KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 16583003 ↗
• InjuryDec 19, 2022Unintended Movement; Unintended Movement

  PATIENT HAD A RP POLY INSITU WHICH SPUN OUT TWICE AND WAS UNABLE TO BE REDUCED. MEDIAL COLLATERAL LIGAMENT DAMAGED (FLEXION GAP LOOSE WITH MID FLEXION INSTABILITY). REVISION SURGERY BOOKED FOR CONVERSION TO ATTUNE REVISION CRS WITH HINGE OPTION AVAILABLE. PREPARED FOR ATTUNE REVISION HOWEVER AT TRAILING KNEE WAS STILL UNSTABLE WITH CRS INSERT - LATERAL COLLATERAL STRETCHED. CONVERTED TO SROM HINGE AND GAINED STABILITY.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16005961 ↗
• InjurySep 29, 2022Unintended Movement; Unintended Movement

  PATIENT UNDERWENT A PRIMARY ATTUNE TKR ON THE (B)(6) 2022. DURING THE PRIMARY SURGERY THE FELLOW NICKED THE MCL BUT ELECTED TO CONTINUE WITH THE PLANNED IMPLANT CONSTRUCT AS IT WAS IN HIS OPINION A "MINOR NICK" AND THE KNEE FELT STABLE AND BALANCED AT TRIAL AND FINAL IMPLANTATION. THE PATIENT STARTED PARTIAL WEIGHT BEARING DURING STANDARD POST OP MOBILITY REHABILITATION, AND THE MCL BECAME MORE DEFICIENT AND THE CR RP INSERT DISLOCATED. THE PATIENT WAS BROUGHT BACK TODAY FOR A FULL REVISION TO AN ATTUNE CRS. IF OTHER, DESCRIBE: N/A. IF OTHER, DESCRIBE: REVISION KNEE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN, INSTABILITY, REVISION SURGERY. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES. IF YES, DESCRIBE: X-RAYS, REVISION SURGERY. OTHER INFORMATION: N/A. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. IP-01532990: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01532991: DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01532992: DEVICE PROPERTY OF: NONE. DEVICE IN POS

  Patient problems: Joint Laxity; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15502863 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO-DOTS. SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS, STIFFNESS, AND DIFFICULTY PROGRESSING WITH ROM. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 15443177 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS WERE REMOVED DUE TO JOINT INFECTION. THERE WERE NO DEFICIENCIES NOTED AND THERE WAS NO DELAY IN PROCEDURE. THE IMPLANTS ARE NOT AVAILABLE FOR RETURN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13407868 ↗
• InjuryMay 10, 2021Unintended Movement; Unintended Movement

  THIS PC REPORTS ABOUT THE SPIN-OUT AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT TKA. SPIN-OUT OCCURRED AFTER SURGERY ON AN UNKNOWN DATE. THE INSERT WAS REPLACED WITH A THICKER ONE ON (B)(6) 2021, BUT SPIN-OUT OCCURRED AGAIN. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11797153 ↗
• InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE PIN GOT STUCK IN THE PROXIMAL TIBIA CUTTING GUIDE. SURGERY WAS EXTENDED BY ABOUT 1 MINUTE WHILE REMOVING THE STUCK PIN.

  Patient problems: No Code Available; Pain

  MAUDE report 10437144 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT UNILATERAL RIGHT KNEE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO PRIMARY OPERATIVE NOTES PROVIDED. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN, EFFUSION, STIFFNESS, AND DECREASED RANGE OF MOTION SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, SCAR TISSUE WAS REMOVED FROM THE TIBIA. THE TIBIAL TRAY WAS GROSSLY LOOSE AND COMPLETELY DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT WAS REVISED WITH DEPUY COMPONENTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Adhesion(s); Edema; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 9992679 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BILATERAL TOTAL KNEES LAST (B)(6) 2019. PATIENT FELT A POPPING SENSATION ON HER LEFT KNEE LAST (B)(6) 2019. REVISION TO A THICKER POLY WAS PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9369053 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT PATIENT HAD BTKA'S ON MONDAY (B)(6) 2019. 3 DAYS POST OP, FELT A "POP" AND DISLOCATED HER RIGHT KNEE. SURGEON REVISED HER TODAY TO A THICKER POLY, OBTAINED A STABLE KNEE. DOI: (B)(6), 2019 DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: Joint Dislocation; Joint Disorder; No Code Available

  MAUDE report 9233057 ↗
• InjuryJan 7, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A VALGUS KNEE. THE SURGEON USED THE PRESCRIBED TECHNIQUE USING A MEASURED SIZER. A SIZE 5 NARROW FEMUR, SIZE 6 TIBIA TRAY AND AS SZ 5 8MM POLY WERE IMPLANTED. THE PATIENT WAS BALANCED IN BOTH EXTENSION AND FLEXION WITH THE 8MM POLY. 3 DAYS LATER THE PATIENT WAS EXPERIENCING SOME PAIN; AN X-RAY WAS TAKEN WHICH SHOWED THAT THE INSERT HAD SPUN OUT. THE SURGEON DID AN MUA AND THEN SUBSEQUENTLY DECIDED TO CHANGE THE POLY. ON MANIPULATION IN THEATER IT WAS QUITE OBVIOUS THAT THE KNEE WAS VERY UNSTABLE. THE 8MM POLY WAS REMOVED AND A SZ5 14MM POLY INSERT WAS IMPLANTED.

  Patient problems: No Code Available; Pain

  MAUDE report 8223209 ↗
• InjuryMay 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE MISPLACEMENT OF INSERT WAS OCCURRED DURING TKA SURGERY ON (B)(6) 2018. FIRST, THE SURGEON IMPLANTED THE IMPLANTS TO THE RIGHT KNEE. THEN, AT THE SAME DAY DURING THE IMPLANTATION SURGERY TO THE LEFT KNEE, THE SURGEON NOTICED THAT THE IMPLANT WHICH IMPLANTED TO THE RIGHT KNEE WAS MISPLACEMENT. THUS, THE IMPLANTS OF THE RIGHT KNEE WERE REVISED TO THE RIGHT POSITION. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7552457 ↗