ATTUNE 1516-40-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10603295049920), received between Nov 7, 2017 and May 12, 2026 — classified as 107 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (10 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 119 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY, SO THE SURGEON UPSIZED THE POLY INSERT. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25149287 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25072439 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS LEFT TOTAL KNEE DONE BY UNKNOWN SURGEON AT AN UNKNOWN LOCATION. THE KNEE IS AN ATTUNE FIXED BEARING PS IMPLANT. PATIENT WAS SHOWING SIGNS OF INSTABILITY AND PATELLA DISLOCATION AND WAS BROUGHT IN FOR REVISION SURGERY. A SIZE 5X5MM INSERT WAS REMOVED AND A NEW 5X8MM FIXED BEARING PS INSERT WAS IMPLANTED. NO DELAY OR COMPLICATIONS IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23757576 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP WAS DONE DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22461011 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANT, THERE WAS SEPTIC MOBILIZATION OF RIGHT KNEE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 22205512 ↗
• InjuryJun 11, 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 PAINFUL LEFT KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22187272 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN ER WITH WARM SWOLLEN KNEE POST TKA. THE SURGEON PERFORMED A THOROUGH I&D WITH INSERT EXCHANGE AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WITH NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 22089087 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO BEING UNSTABLE. THE DOCTOR DID POLY SWAP AND WENT UP TO A 5-6MM. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN , DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21969546 ↗
• MalfunctionFeb 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE INSERT COULD NOT BE LOCKED. THE SIZE OF THE INSERT WAS INCORRECT, RESULTING IN THE INABILITY TO MATCH THE CORRESPONDING SIZE OF TIBIAL PLATEAU. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459954 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD I&D POLY EXCHANGE DUE TO INFECTION. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAYS. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21181048 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A UTI ROUGHLY ONE MONTH AGO, AND THE SURGEON BELIEVES IT SEEDED HER TOTAL KNEE AS THE PATIENT HAD BEEN DOING QUITE WELL PRIOR TO THIS EVENT. ALL WELL FIXED, WELL ALIGNED AND WELL FUNCTIONING IMPLANTS WERE REMOVED AND REVISED IN A ONE STAGE REVISION KNEE FOR INFECTION. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21149600 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND LIMITED EXTENSION AND MOBILITY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20744977 ↗
• MalfunctionSep 25, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: B. WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT?: NO. C. WHAT WAS THE ALLEGATION AGAINST THE INSERT?: THE SURGEON HAMMERED IN THE 5 MM INSERT AS USUAL, BUT THE PART ON THE MEDIAL SIDE OF THE LEFT LEG DIDN¿T FIT, AND THE GAP REMAINED. D. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT?: LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305497 ↗
• MalfunctionJul 22, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON OPENED THE ATTUNE PS INSERT AND IT WOULD NOT CLICK INTO TIBIAL TRAY. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791645 ↗
• InjuryJul 11, 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 UNDERWENT THE PRIMARY SURGERY VIA TKA OA FOR BOTH KNEE JOINT WITH THE IMPLANT IN QUESTION. ON (B)(6) 2024, THE PATIENT COMPLAINED OF PAIN ON THE RIGHT SIDE, WHICH WAS EXAMINED AND FOUND TO BE INFECTED. THEREFORE, THE RIGHT IMPLANTS WERE REMOVED ON (B)(6) 2024 AND THE AFFECTED AREA WAS CLEANED. THE SURGEON DIAGNOSED IT AS CEMENT MOLD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19722498 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, REVISION WAS COMPLETED, DUE TO RESTRICTED RANGE OF MOTION. IMPLANTS WERE WELL FIXED, APPROPRIATELY SIZED, WELL ALIGNED. AND JOINT LINE APPEARED APPROPRIATE, BUT CONSERVATIVE TREATMENTS HAD FAILED TO INCREASE MOTION. NO SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19689319 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO, THERE WAS NO DELAY.

  Patient problems: Pain

  MAUDE report 19539606 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO DELAY WAS IDENTIFIED. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO INSTABILITY WAS REPORTED DUE TO THE POLYETHYLENE WEAR. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO.

  Patient problems: Fibrosis; Joint Laxity

  MAUDE report 19164913 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRIOR TOTAL KNEE SURGERY ON (B)(6) 2024 AND CAME BACK FOR A POLY SWAP BECAUSE OF SUSPECTED INFECTION DONE AT SAME HOSPITAL. THERE WAS NO LOOSENING. DOI: ON (B)(6) 2024 , DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19115371 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 IRRIGATION AND DEBRIDEMENT OF THE KNEE WERE PERFORMED, AND THE POLY WAS EXCHANGED WHILE IN THE CAPSULE. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19098445 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND NEEDED A WASHOUT/POLY SWAP. DOI: ON (B)(6) 2024 ,DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 19051879 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY UTILIZING DEPUY SYNTHES IMPLANTS INCLUDING PATELLA AND CEMENT X 2. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SECONDARY TO DISCOMFORT, FALLS, JOINT INSTABILITY, AND A POSITIVE BONE SCAN WITH SUSPECTED TIBIAL LOOSENING. INTRAOPERATIVELY, HYPERTROPHIC SYNOVIAL AND GRANULATION TISSUE WAS IDENTIFIED. LOOSENING AT THE IMPLANT TO CEMENT INTERFACE WAS CONFIRMED. (B)(6) 2015 DOI. (B)(6) 2023 DOR (RIGHT KNEE).

  Patient problems: Discomfort; Fall; Joint Laxity; Synovitis

  MAUDE report 18894597 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE IMPLANT IN QUESTION. ON AN UNKNOWN DATE, INFECTION WAS CONFIRMED. THEREFORE, REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18737762 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS SUSPECTED LOOSENING OF COMPONENTS. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18606446 ↗
• InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED: NO SURGICAL DELAY REPORTED. THE SURGEON DIAGNOSED A RUPTURED CAPSULE ON PATIENT'S CHART.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 18393105 ↗

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