ATTUNE 1516-40-806Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10603295050353), received between Sep 7, 2017 and Apr 8, 2026 — classified as 42 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 45 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING PAIN AND SHOWED SIGNS OF HAVING A LOOSE IMPLANT. DOCTOR REVISED BOTH THE FEMORAL SIDE AND THE TIBIAL SIDE. DOI- UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24821029 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO DOCTOR DUE TO INABILITY TO FULLY EXTEND THE KNEE. THE DOCTOR THOUGHT IT WAS BEST TO RELEASE SOME SOFT TISSUE AND PUT IN A THINNER POLY SO THE PATIENT COULD STRAIGHTEN HIS KNEE. ORIGINALLY PATIENT HAD A 6MM POLY AND THE DOCTOR IMPLANTED A 5MM AFTER RELEASING SOFT TISSUE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 24779523 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP FOR INFECTION. SAME SIZE INSERT WAS IMPLANTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24071152 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LINER EXCHANGE TO RULE OUT INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24067630 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTED KNEE, ALL COMPONENTS REMOVED. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23959869 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COULD NOT ACHIEVE FULL FLEXION. SURGEON REMOVED THE OLD FEMORAL COMPONENT AND SWAPPED IT FOR A FEMORAL COMPONENT A SIZE SMALLER. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 23789601 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23544887 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2025. THE PATIENT FELL AND COMPLAINED ABOUT HIS KNEE HURTING. THE PATIENT HAD DAMAGED HIS TIBIA WHICH CAUSED THE TIBIA IMPLANT TO LOOSEN. THE DOCTOR DECIDED THAT A FULL KNEE REVISION KNEE WAS NEEDED FOR STABILITY.

  Patient problems: Bone Notching; Fall; Joint Laxity; Pain

  MAUDE report 22457016 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WASHED OUT. DOCTOR DECIDED TO REPLACE POLY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 20426781 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS SUSPECTED INFECTION S/P KNEE TAP IN OFFICE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20238164 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS SWAPPED DUE TO A POSSIBLE INFECTION. THERE WAS NO DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 19486278 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN 2014, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE ATTUNE INSERT IN QUESTION AT ANOTHER HOSPITAL. SINCE THE PRIMARY SURGERY WAS PERFORMED AT ANOTHER HOSPITAL, INFORMATION OTHER THAN THE YEAR OF THE SURGERY IS NOT AVAILABLE. ON (B)(6) 2024, THE SALES REP WAS INFORMED THAT A REVISION SURGERY WAS SCHEDULED TO REPLACE THE ATTUNE INSERT IN QUESTION. THE REVISION SURGERY IS SCHEDULED FOR (B)(6). THE CAUSE OF REVISION SURGERY IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. (B)(4) COMPLAINT IS RELATED TO (B)(4) AS THE PATIENT RECEIVED TWO INSERT REVISIONS ON TWO DIFFERENT DATES.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 19280354 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGE WAS DONE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19072151 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED POLY FOR INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024 AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19072111 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY UTILIZING DEPUY SYNTHES IMPLANTS INCLUDING PATELLA AND CEMENT X 1. ON (B)(6) 2022, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SECONDARY TO PAIN, JOINT INSTABILITY AND SUSPECTED TIBIAL TRAY LOOSENING. INTRAOPERATIVELY, SCAR TISSUE AND SYNOVITIS WAS IDENTIFIED. THE TIBIAL TRAY WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THERE WAS BONE LOSS NOTED ON THE POSTERIOR ASPECT OF THE FEMORAL CONDYLES. ALL COMPONENTS WERE REMOVED AND REVISED TO A COMPETITOR CONSTRUCT WITH EXCEPTION OF THE PATELLA THAT REMAINED IN SITU. (B)(6) 2017 DOI; (B)(6) 2022 DOR (RIGHT KNEE).

  Patient problems: Adhesion(s); Joint Laxity; Pain; Synovitis

  MAUDE report 18913218 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. DOI: (B)(6) 2016, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18597676 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN 2014, THE PATIENT UNDERWENT THE PRIMARY SURGERY VIA TKA WITH THE IMPLANT IN QUESTION AT ANOTHER HOSPITAL. ON AN UNKNOWN DATE, THE PATIENT WAS CONFIRMED INFECTED. THEREFORE, A REOPERATION WAS PERFORMED ON (B)(6) 2023, WITH CLEANING AND CURETTAGE OF THE INFECTED AREA AND REPLACEMENT OF THE INSERT. A NEW IMPLANT OF THE SAME THICKNESS AS THE ONE USED WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18424526 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY WAS EXCHANGED. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2021. DOR: DEC 18, 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18401950 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI: (B)(6) 2023. DOR: DECEMBER 12, 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18356556 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TKA INFECTION. INSERT WAS EXCHANGED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17850291 ↗
• InjuryAug 16, 2023Adverse 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) WITH POLY EXCHANGED FOR CONFIRMED INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17556911 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ATTUNE INSERT EXCHANGE DUE TO REDUCED RANGE OF MOTION. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 17479770 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. SURGEON UPSIZED POLY FOR A MORE STABLE CONSTRUCT. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15728200 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS PERFORMED DUE TO INFECTION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15528047 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. POLY WAS SWAPPED. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15462311 ↗

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