ATTUNE 1516-50-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10603295052715), received between Sep 21, 2017 and Jan 23, 2026 — classified as 85 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN ATTUNE OCCURRED DUE TO INFECTION. ORIGINAL SURGERY WAS DONE ABOUT TWO YEARS AGO. EXACT DATE UNKNOWN. RIGHT SIDE. COMPONENTS WERE WELL FIXED. ALL COMPONENTS WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 24167159 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I & D OF LEFT KNEE POLY SWAP. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE-LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23876612 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22689259 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. A POLY EXCHANGE WAS PERFORMED AS WELL AS A DEBRIDEMENT AND PLACEMENT OF ANTIBIOTIC BEADS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22641753 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS A STAGE 1 KNEE REVISION. SURGEON TOOK OUT ALL COMPONENTS AND PUT IN AN ANTIBIOTIC SPACER TO RULE OUT INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22522491 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH I&D AND POLY SWAP (TIBIAL)INSERT OF LEFT KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22088446 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INFLAMMATION IN THE KNEE DUE TO RECENT FALL. SURGEON EXAMINED TO FIND POSSIBLY HYPER EXTENSION AND MCL STRAIN. VIVID DAMAGE OF AN MCL TEAR APPEARED DURING SURGERY. AN MCL REPAIR WAS PERFORMED AS WELL AS A POLYETHYLENE EXCHANGE. AFFECTED AREA: LEFT KNEE.

  Patient problems: Fall; Inflammation; Loss of Range of Motion; Unspecified Tissue Injury

  MAUDE report 22046232 ↗
• InjuryApr 30, 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 KNEE INSTABILITY. DOCTOR UPSIZED THE INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21936539 ↗
• InjuryFeb 4, 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 FIBROSIS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 21307123 ↗
• 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 FOR PAINFUL RIGHT KNEE. PATIENT HAD A SIGNIFICANT FLEXION CONTRACTURE. THE SURGEON OPTED FOR A FEMORAL TIBIAL REVISION TO BALANCE THE KNEE. DOI: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture; Pain

  MAUDE report 21222554 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20532504 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL POST OP AND OPENED HIS WOUND. BROUGHT BACK TO OR FOR IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 20514187 ↗
• MalfunctionAug 19, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  RIGHT TKR. ATTUNE PS RP SZ7 6MM INSERT WAS OPENED AND THE SURGEON NOTICED SMALL SHAVINGS OF POLY STILL ATTACHED TO THE INSERT WHEN HE WENT TO PULL IT OUT OF THE CONTAINER THE POLY WAS BEING HELD IN. THE LITTLE POLY HAIRS/SHAVINGS WERE VERY FINE, AND REP COULD EVEN PHOTOGRAPH THEM. THE INSERT WAS NOT IMPLANTED (WE USED ANOTHER IMPLANT). THE POLY INSERT WAS NOT ANYWHERE NEAR THE PATIENT WHEN NOTICED AND IN THE INSERT WAS DISCARDED AS IT HAD BLOOD ON IT FROM THE SURGEONS GLOVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000004 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS RIGHT KNEE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 19793862 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING REVISED DUE TO INFECTION. ALL HARDWARE FROM A PRIMARY TOTAL KNEE WAS REMOVED AND A CEMENT SPACER WAS PLACED IN THE PATIENT. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19192041 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18912688 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18640713 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18319459 ↗
• InjuryNov 30, 2023Adverse 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 PAIN. SURGEON REMOVED 6MM INSERT AND REPLACED WITH 10MM INSERT. DOI: (B)(6) 2017, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18236572 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AT THE UNKNOWN INTERFACE AND PAIN. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18038603 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SYNOVITIS. THERE WAS A HEAVY SCAR TISSUE. PATIENT WAS HAVING LIMITED KNEE MOTION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Synovitis

  MAUDE report 17930261 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH INSTABILITY. POLY SWAP WAS NECESSARY. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17745533 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY EXCHANGE DUE TO INSTABILITY. DOI: UNKNOWN. DOE: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17623671 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AS IT WAS TOO TIGHT IN EXTENSION. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 17497985 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH AN INFECTION. THE SURGEON DECIDED IT BEST TO IRRIGATE THE KNEE AND SWAP THE POLY. HE USED THE SAME SIZE AFTER TRIALING. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17125276 ↗