ATTUNE 1516-40-808Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295050377), received between Nov 6, 2018 and Aug 12, 2026 — classified as 32 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

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

  It was reported that the patient was revised due to pain, instability and loosening of the tibial component at the cement to implant interface. DePuy cement was used. DOI: Unknown.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Joint Laxity; Pain

  MAUDE report 50224378 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND UNDERWENT REVISION SURGERY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23817441 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE AND UNDERWENT REVISION FROM 8-8MM POLY TO 8-10 MM POLY. THERE WAS NO DELAY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22825674 ↗
• MalfunctionApr 29, 2025Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING A KNEE SURGERY, WHEN TRYING TO PLACE THE INSERT ON THE TIBIAL BASE, IT COULD NOT BE DONE BECAUSE THE INSERT WAS DEFORMED ON THE HITCH. THE SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT. ANOTHER IMPLANT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21928669 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21724022 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DENTAL PROCEDURE RECENTLY AND THEN HE GOT AN INFECTION IN HIS KNEE. COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21546812 ↗
• MalfunctionJan 23, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THE IMPLANT DID NOT SEAT ALL THE WAY DOWN AND PART OF THE POLY BROKE OFF. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219053 ↗
• InjuryJan 23, 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 INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21217222 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INFECTION. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20918850 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D). DOI: (B)(6) 2015. DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE SIDE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 19352206 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RULE OUT INFECTION. LINER WAS EXCHANGED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19096191 ↗
• InjuryDec 12, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  HCP IS REPORTING TO NCA/BFARM: "(B)(6) 2023: IMPLANTATION OF KNEE-TEP: BICONDYLAR SURFACE REPLACEMENT PROSTHESIS: CEMENTED LEFT (5-822.G1) IMPLANTATION OF AN ENDOPROSTHESIS AT THE KNEE JOINT: PATELLAR REPLACEMENT: PATELLAR BACK SURFACE, CEMENTED LEFT (5-822.81). AFTER KNEE-TEP IMPLANTATION INITIALLY SYMPTOM-FREE INTERVAL OF 4 MONTHS. CRACKING NOISE WITH FORCED FLEXION DURING PHYSIOTHERAPY. IN THE COURSE PROGRESSING FEELING OF INSTABILITY IN THE AREA OF THE LEFT KNEE AND INTERMITTENT PAIN. RADIOLOGICALLY NO ABNORMALITY IS EVIDENT, OPTIMAL KNEE-TEP IN FLEXION AND EXTENSION AS WELL AS OPTIMAL INTEGRATION OF THE IMPLANTED IMPLANTS. (B)(6) 2023: DURING THE REVISION SURGERY A DISLOCATION OF THE INLAY IS DETECTED. THE INLAY IS LIFTED OUT OF THE GUIDE RAISED IN VENTRAL DIRECTION. THIS RESULTS IN A CORRESPONDING VENTRAL DISLOCATION OF THE INLAY. CHANGE OF INLAY TAKES PLACE.".

  Patient problems: Joint Laxity; Pain

  MAUDE report 18309667 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) DUE TO INFECTION AND POLY SWAP. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17556473 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT WITH POLY SWAP WAS DONE. DOI: (B)(6), 2023, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16794845 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATIENT STRUGGLING WITH LEFT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: ON (B)(6) 2021, DATE OF EVENT: ON (B)(6) 2021. (LEFT KNEE). TREATMENT: PAIN MEDICATION.

  Patient problems: Pain

  MAUDE report 16372136 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16088678 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CONFIRMED INFECTION. I AND D WITH POLY EXCHANGE WAS DONE. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15321322 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15182550 ↗
• MalfunctionJul 25, 2022Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  SURGEON INDICATES THAT THE ATTUNE SYSTEM INSERT 8 X 8 MM IMPLANT COULD NOT BE PLACED IN THE PATIENT, AFTER HAVING SUCCESSFULLY CARRIED OUT ALL THE TESTS USING THE 8 X 8 MM INSERT PREVIOUS TEST PIECE FOUND IN THE INSTRUMENTS. THEREFORE, THE SURGEON INDICATES THAT THE IMPLANT MUST HAVE SOME MANUFACTURING DEFECT. HE FINALLY PLACED THE FINAL INSERT 8 X 7 MM, WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094478 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MANIPULATION UNDER ANAESTHETIC (MUA) TO ADDRESS STIFFNESS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2019 (REVISION SURGERY, ALL PRODUCTS). DOE: (B)(6) 2019. (LEFT KNEE).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 14111139 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13618179 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN I&D AND A POLY EXCHANGE WERE PERFORMED FOR CONFIRMED INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12467067 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12467045 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12466853 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. WENT UP 2 POLY SIZES. NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11957217 ↗

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