ATTUNE 1516-40-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295049814), received between Aug 18, 2017 and Apr 13, 2026 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 33 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 UPSIZED POLY BECAUSE TOO LOSE IF EXTENSION. NO IMPLANT FAILURE. NO LOOSENING OR INFECTION. NO OTHER INFORMATION KNOWN. DOI: UNKNOWN. DOR: MARCH 27, 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24863220 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD FLEXION CONTRACTURE. SURGEON DID MUA AND CHANGED POLY SIZE. DOI: (B)(6) 2025. DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Septic loosening

  MAUDE report 22416104 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT WAS PATIENT RECEIVED A CEMENTED PRIMARY LEFT ATTUNE POSTERIOR STABILIZED FEMUR AND FIXED BEARING S+ TIBIAL TRAY TOTAL KNEE REPLACEMENT, WITH RESURFACED ANATOMIC PATELLA. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6) 2019, THE PATIENT WAS TREATED WITH A MANIPULATION UNDER ANESTHESIA OF THE LEFT TOTAL KNEE ARTHROPLASTY, AS WELL AS AN INTRA-ARTICULAR STEROID INJECTION OF THE LEFT KNEE, ADDRESSING KNEE STIFFNESS. THERE WERE NO COMPLICATIONS. ON (B)(6) 2020, THE PATIENT¿S LEFT TOTAL KNEE ARTHROPLASTY WAS REVISED TO ADDRESS PAIN AND INSTABILITY. PATIENT DEMONSTRATED SIGNIFICANT LAXITY IN FLEXION AND EXTENSION, AND SO THE ATTUNE INSERT WAS REVISED. FEMUR, TIBIAL TRAY, AND PATELLA WERE FOUND TO BE WELL-FIXED AND POSITIONED, WITH THE PATELLA TRACKING WELL; AND WERE ALL RETAINED. ON (B)(6) 2022, PATIENT¿S LEFT KNEE WAS REVISED TO ADDRESS TIBIAL TRAY IMPLANT LOOSENING. THE FEMORAL COMPONENT WAS FOUND TO BE WELL-FIXED AND POSITIONED BUT WAS EXTRACTED USING OSTEOTOMES. THE TIBIAL TRAY WAS FOUND TO BE LOOSE, DE-BONDED FROM THE BONE CEMENT AT THE CEMENT TO IMPLANT INTERFACE, BEING SIMPLY REMOVED WITH ONLY A TAMP. FEMUR, TIBIAL TRAY, AND INSERT WE

  Patient problems: Joint Laxity; Pain

  MAUDE report 21537149 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A MANIPULATION UNDER ANESTHESIA OF THE LEFT TOTAL KNEE ARTHROPLASTY, AS WELL AS AN INTRA-ARTICULAR STEROID INJECTION OF THE LEFT KNEE, ADDRESSING KNEE STIFFNESS. THERE WERE NO COMPLICATIONS. AFFECTED KNEE: LEFT.

  Patient problems: Muscular Rigidity

  MAUDE report 21535514 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATED KNEE WAS PLACED IN 2015, BUT NO RECORDS WERE ABLE TO FOUND OF PREVIOUS SURGERIES. PATIENT COMPLAINED OF DISCOMFORT AND INSTABILITY AND IT WAS NOTED ON EXAM. X-RAYS DID NOT SHOW ANY SIGNS OF LOOSENING, SUBSIDENCE OR MALALIGNMENT. A SIZE 4 8MM FB PS INSERT WAS REMOVED. A THICKER INSERT WAS PLACED WITHOUT DELAY OR PATIENT HARM. ALIGNMENT, JOINT LINE, AND COMPONENT SIZES ALL APPEARED APPROPRIATE. NO WEAR WAS APPARENT. ALL COMPONENTS WERE WELL FIXED. SURGEON BELIEVED SHE SIMPLY STRETCHED OUT OVER TIME AS HER CONTRALATERAL KNEE REPLACEMENT OF THE SAME DESIGN WAS WELL FUNCTIONING. DOI: (B)(6) 2015. DOR: (B)(6) 2024 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 20566586 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND KNEE BECAME UNSTABLE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Joint Laxity

  MAUDE report 20345298 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA WITH THE INSERT IN QUESTION. ON (B)(6) 2024, IT WAS CONFIRMED THAT THE PATIENT WAS INFECTED. THEREFORE, THE INSERT IN QUESTION WAS REMOVED AND THE AFFECTED AREA WAS TREATED FOR DEBRIDEMENT AND CLEANED. THE INSERT WAS THEN REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 19372414 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TOTAL KNEE REPLACEMENT EXCESSIVE BLEEDING WAS NOTED FROM THE BACK OF THE KNEE. THE SURGEON WORKED ON CONTROL OF THE BLEEDING. THE KNEE WAS IMPLANTED AND WHEN THE TOURNIQUET WAS LET DOWN THERE WAS MORE BLEEDING. THE INSERT IMPLANT WAS REMOVED TO ACCESS THE BACK OF THE KNEE JOINT. A VASCULAR SURGEON WAS CALLED AND CAME TO REPAIR THE VESSEL. DURING THIS PORTION OF THE PROCEDURE SALES REP LEFT THE ROOM. SALES REP RETURNED LATER AND A NEW INSERT WAS IMPLANTED. THE DELAY WAS RELATED TO THE BLEEDING. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 19190915 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN , DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19115875 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND NEEDED A PATELLA REALIGNMENT. THE SURGEON DECIDED TO TRIAL A LARGER POLY SIZE AND INSERT A 4X10 MM INSERT PSFB. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 18393152 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POST TRAUMATIC FALL AND HAD AN IRRIGATION AND DEBRIDEMENT. THE INSERT WAS EXCHANGED. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6), RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 18365817 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSERT EXCHANGE FROM POST TRAUMATIC FALL. MCL REPAIR. NO EXTENDED TIME AND NO BROKEN INSTRUMENTS OR IMPLANTS. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 18363781 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. DOI- (B)(6) 2017; DOR- (B)(6) 2023; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18139707 ↗
• InjuryOct 18, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING THE TOTAL RIGHT KNEE REPLACEMENT PROCEDURE, THE 4*8 TIBIAL INSERT IS PASSED SINCE THE FEMORAL COMPONENT WAS 5, THE CORRESPONDING INSERT SHOULD BE A 5*8. BUT IT WAS ONLY REALIZED AT THE TIME OF MAKING THE CONSUMPTION REPORT, SO INFORMED THE SPECIALIST OF THE NEWS. THE SPECIALIST MAKES THE DECISION TO CHANGE THE INSERT, THEREFORE IT IS NECESSARY TO REOPERATE ON THE PATIENT AND INSERT THE 5*8" INSERT.

  Patient problems: Insufficient Information

  MAUDE report 17957843 ↗
• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16529842 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS POLY SWAP. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15614371 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15427631 ↗
• InjuryJun 10, 2022Adverse 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 INFECTION. THERE WAS A POLY SWAP. DOI: UNKNOWN, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14654807 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12452431 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS STIFF SO THE SURGEON TOOK OUT AN 8MM POLY AND REPLACED WITH 6MM POLY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, NO SURGICAL DELAY.

  Patient problems: Muscular Rigidity

  MAUDE report 11665201 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS NOT RESURFACED, AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO ASEPTIC LOOSENING. UPON ENTERING THE JOINT, IT IS INDICATED THAT SCARRING WAS REMOVED. THE TIBIAL COMPONENT WAS LOOSE, INTERFACE NOT PROVIDED. THE FEMORAL AND INSERT COMPONENTS WERE ALSO REVISED WITHOUT INDICATION OF PRODUCT DEFICIENCY. DEPUY PRODUCTS WERE IMPLANTED, THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 11154964 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT KNEE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11088146 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. FRANK PUS WAS ENCOUNTERED. THE KNEE WAS WASHED OUT AND A NEW INSERT WAS PLACED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

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

  MAUDE report 10935485 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIBIAL COMPONENT WAS REVISED DUE TO KNEE PAIN. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2016; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10757028 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANOTHER SURGERY ON (B)(6) 2020 BY REMOVING ALL IMPLANTS. THE SURGEON PLACED CEMENT MOLD INTO THE BODY, AND HE IS WAITING QUIESCENCE OF THE INFECTION. DOI: (B)(6) 2020 ( TIBIAL INSERT ONLY). DOR: (B)(6) 2020. UNKNOWN KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10174228 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507