ATTUNE LPS 1517-60-214Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295490975), received between Jan 5, 2021 and Sep 29, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that surgeon revised poly due to infection. Washed out and debrided knee, and swapped poly.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Unknown.

  Patient problems: Unspecified Infection

  MAUDE report 50931231 ↗
• InjuryAug 26, 2026Fracture; Device Dislodged or Dislocated

  It was reported that the implant had to be revised due to dislocation. During surgery it was observed that the polyethylene component had dissociated from the metal inner.

  Patient problems: Joint Dislocation

  MAUDE report 50454176 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SURGEON REPLACED POLY AND HINGE PIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22592892 ↗
• InjuryDec 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED THE LPS POLY FROM THE TIBIAL BASE PLATE. PATIENT SAID THAT SHE WAS CROSSING HER LEGS TO PUT ON A SOCK WHEN THE EVENT HAPPENED. SHE SAID THAT SHE HAD BUCKLING SENSATIONS PRIOR TO THIS DISLOCATION. PATIENT HAS ALSO HAD MULTIPLE SOFT TISSUE SURGERIES PRIOR TO THIS SURGERY ONE BEING AN EXTENSION MECHANISM REPAIR. THE SURGEON UPSIZED HER POLY FROM A 14MM TO 23MM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 20918887 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND POLY WAS EXCHANGED. PUSS WAS PRESENT. CULTURES SHOWN POSITIVE RESULT. DOI: (B)(6) 2022. DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20350971 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE LINER WAS EXCHANGED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16408765 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTION. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16121162 ↗
• InjuryOct 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED THE INSERT FROM THE TIBIA. THE MAIN ISSUE WAS WITH THE PATELLA. REPLACED POLY AND FIXED THE PATELLA. DOI- (B)(6) 2022, DOR- (B)(6) 2022, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 15526273 ↗
• InjurySep 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. LINER WAS EXCHANGED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15461891 ↗
• InjuryAug 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL CAUSING AN OPEN DISLOCATION OF THE DISTAL FEMORAL REPLACEMENT. THE POLY, PIN AND THE BUMPER WERE CHANGED. THE DISTAL FEMORAL COMPONENT WAS NOT REMOVED. THERE WAS NO REPORTED LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15197844 ↗
• InjuryMay 7, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  SURGEON MADE REP AWARE THAT A PATIENT WITH A LPS-ATTUNE REV CONSTRUCT IN DISLOCATED THE POLY INSERT AND WOULD NEED TO COME IN FOR REVISION SURGERY TO EXCHANGE THE POLY INSERT FOR A THICKER ONE. THE INSERT WAS A ATTUNE REVISION-LPS 14MM X-SMALL INSERT. SURGEON STATED THAT THE PATIENT HAD A DISLOCATED PATELLA, WHICH RESULTED IN A LACK OF ANTERIOR STABILITY OF THE KNEE, WHICH RESULTED IN THE FEMUR TRANSLATING ANTERIORLY AND DISLOCATING THE POLY INSERT. AT THE TIME OF SURGERY, WHEN THE KNEE WAS OPENED UP, THE SURGEON FOUND THAT THE POLY INSERT HAD DISSOCIATED FROM THE METAL CORE THAT IS PART OF THE INSERT. THIS MEANS THAT THE METAL CORE WAS STILL ATTACHED TO THE FEMORAL COMPONENT VIA THE HINGE PIN; HOWEVER, THE REST OF THE POLY INSERT WAS NOT ATTACHED TO ANY OTHER PART OF THE CONSTRUCT. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Joint Laxity

  MAUDE report 14315930 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND OPEN WOUND. I&D AND POLY EXCHANGE PROCEDURE WAS DONE. LABORATORIES WERE NOT BACK FOR EXACT ORGANISM. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 11118708 ↗