ATTUNE 1516-40-612Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295050117), received between Feb 1, 2019 and Apr 28, 2026 — classified as 18 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD LOOSE POLY. JUST A QUICK SWAP. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 25018571 ↗
• MalfunctionAug 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WAS NOT LOCKING IN CORRECTLY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792218 ↗
• MalfunctionAug 8, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT THE LOCK ON THE INSERT WAS BROKEN AND WOULD NOT ATTACH TO THE TIBIAL BASE. A NEW INSERT WAS OPENED TO REPLACE THE BROKEN IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749686 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AND UNDERWENT INSERT EXCHANGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22152931 ↗
• InjuryFeb 24, 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 JOINT INFECTION. POLY SWAP. SAME SIZE POLY PUT BACK IN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21445537 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 17878469 ↗
• MalfunctionSep 6, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT BOTH POLYS DID NOT SEAT WHEN BEING IMPACTED. SURGICAL DELAY IS UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689404 ↗
• MalfunctionSep 5, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT BOTH POLYS DID NOT SEAT WHEN BEING IMPACTED. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOE: (B)(6) 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685906 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT I&D AND POLY EXCHANGE FOR THE LEFT KNEE. NO SURGICAL DELAY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17361757 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR UNSTABLE KNEE. THERE WAS FEMORAL REVISION. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16742272 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS A LITTLE UNSTABLE. GOING UP IN POLY SIZE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16145609 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A KNEE INFECTION. THE KNEE WAS WASHOUT AND THE POLY INSERT WAS SWAPPED OUT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14787067 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSE IN EXTENSION AND FLEXION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14742919 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY DUE TO FALL. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 14689186 ↗
• InjuryJun 17, 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) 2016; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12017406 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY WAS REVISED. DOI: (B)(6) 2019; DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11499201 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11337576 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11028018 ↗
• InjuryJan 8, 2020Naturally Worn; Naturally Worn

  ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE DEPUY KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, INSTABILITY, AND PAIN. THE SURGEON REPORTED WEAR TO THE POSTEROMEDIAL ASPECT OF THE POLYETHYLENE. HE ALSO NOTED THE TIBIAL COMPONENT WAS GROSSLY LOOSE AND APPEARED NOT TO BE FIX AT ALL AND LIFTED OUT. THERE WAS NO CEMENT ON THE TIBIAL COMPONENT AT THE COMPONENT TO CEMENT INTERFACE. THE FEMORAL COMPONENT WAS REMOVED WITH FLEXIBLE OSTEOTOMES. THE PATELLA WAS RETAINED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2014. DOR: (B)(6) 2019 (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9563903 ↗
• InjuryOct 3, 2019Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 13 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS WITH SEVERE VALGUS. IT WAS NOTED THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE DEPUY KNEE SYSTEM. COMPETITOR CEMENT WAS UTILIZED IN THE PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE PATELLAR BUTTON, LOOSE FEMORAL COMPONENT, OSTEOLYSIS, PATELLA AND PAIN. THE SURGEON INDICATED THE PATELLAR BUTTON WAS REMOVED AS IT WAS COMPLETELY LOOSE AND WAS REVISED. HIS-POST OPERATIVE NOTE INDICATED HE REPAIRED A FRACTURED PATELLA, BUT THE OPERATIVE NOTES DO NOT OFFER THE CAUSE NOR NATURE OF THE FRACTURE. THE SURGEON REPORTED SOME THIRD-BODY WEAR NOTED ON THE POLY LINER. THE SURGEON NOTED THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE AND REMOVED WITH EASE, THOUGH HE DID NOT SPECIFY THE INVOLVED INTERFACE. THERE WERE NO COMPLAINTS REGARDING THE TIBIAL COMPONENT, THOUGH IT WAS REVISED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. DEPUY COMPONENTS WERE IMPLANTED IN THE REVISION. COMPETITOR CEM

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 9152925 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A PAINFUL KNEE. THE SURGEON WAS PERFORMED AN IRRIGATION AND DEBRIDEMENT AND REPLACED THE TIBIAL INSERT KNEE WAS STABLE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9077753 ↗
• InjuryFeb 1, 2019Loose or Intermittent Connection; Separation Problem; Loose or Intermittent Connection; Separation Problem

  IT WAS REPORTED THAT THE TIBIAL INSERT CAME LOOSE FROM THE TIBIAL LOCKING MECHANISM.

  Patient problems: No Code Available

  MAUDE report 8297194 ↗

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