ATTUNE 1516-40-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10603295050070), received between Aug 16, 2017 and Apr 29, 2026 — classified as 85 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 91 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 25027655 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP ON AN INFECTED PATIENT. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24872717 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS LOOSE IN EXTENSION, AND THEY WENT UP IN THE POLY THICKNESS. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24832026 ↗
• InjurySep 19, 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. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23096439 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE HEAD AND CUP.

  Patient problems: Joint Laxity

  MAUDE report 22743002 ↗
• InjuryJul 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 PAIN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22589486 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A THICKER POLY FOR KNEE STABILITY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22375350 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SOME SWELLING IN THE KNEE AND WAS TAKEN INTO SURGERY ON (B)(6) 2025 FOR AN I&D TO RULE OUT AN INFECTION. THE POLY WAS REMOVED, AND THE JOINT SPACE WAS IRRIGATED. A NEW POLY WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22335871 ↗
• InjuryJun 6, 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. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22157764 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INSTABILITY AND THE TIBIAL TRAY WAS LOOSE. CEMENT WAS STILL ON THE BOTTOM OF THE TRAY, SO IT LOOKED TO BE FROM THE CEMENT BONE INTERFACE. REVISION WAS PERFORMED. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21874645 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DISLOCATED PATELLA, SEVERE FLEXION CONTRACTURE, AND FLEXION/EXTENSION MISMATCH. JOINT WAS EXPLANTED. TEMPORARY SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Contracture; Joint Laxity

  MAUDE report 21571406 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ABOUT 7 DAYS POST TKA, PATIENT'S KNEE WOUND HAD OPENED UP BECAUSE PATIENT HAD BEEN PICKING AT IT. AN IRRIGATION WAS DONE ALONG WITH A POLY EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 20077563 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POLY SWAP DUE TO A PRICE OF BONE BOTHERING PATIENT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19831551 ↗
• InjuryJun 25, 2024Adverse 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. DOI: (B)(6) 2024. DOR: (B)(6) 2024 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19606284 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POSSIBLE INFECTION, SO SURGEON DID A WASHOUT WITH A POLY EXCHANGE. LOT NUMBER OF EXPLANT WAS UNKNOWN AND DATE OF ORIGINAL SURGERY WAS UNKNOWN. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19574223 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER JOINT REPLACEMENT PROCEDURE, POOR PATIENT COMFORT WAS REPORTED DUE TO PATIENT'S OWN REASON, NOT PRODUCT CAUSE. THUS, DISCUSSED WITH HIS/HER DOCTOR, A SECOND SURGERY WAS PERFORMED TO REPLACE THE APPROPRIATE DEVICE.

  Patient problems: Discomfort; Pocket Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 19058315 ↗
• MalfunctionMar 4, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO IMPACT THE ATTUNE STABILIZED INSERT INTO THE TIBIAL TRAY FOUR TIMES, HOWEVER, IT WOULD NOT SEAT POSTERIORLY INTO THE TIBIAL TRAY. THE SURGEON ASKED FOR A NEW POLY INSERT AND IT SEATED AND WAS EASILY IMPACTED ON THE FIRST ATTEMPT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825741 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18684920 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD DEVELOPED A FLEXION CONTRACTURE AND COULD NO LONGER ACHIEVE FULL EXTENSION. OPERATIVELY, IT WAS NOTED THAT THE PATIENT HAD A FLEXION EXTENSION MISMATCH. COMPONENTS WERE REMOVED AND A REVISION HINGED KNEE WAS PLACED UNEVENTFULLY. ALL COMPONENTS WERE APPROPRIATELY SIZED, WELL ALIGNED, WELL FIXED WITH AN APPROPRIATE JOINT LINE. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. CEMENT WAS HOSPITAL OWNED SO NO RECORDS ARE AVAILABLE. PATELLAR IMPLANT WAS RETAINED FROM INITIAL SURGERY AS IT WAS WELL FIXED AND TRACKED APPROPRIATELY. PATIENT DID HAVE AN ADDITIONAL SURGERY ON (B)(6) 2022 AND WAS CAPTURED IN (B)(4). THE INSERT WAS EXCHANGED AT THAT TIME, HOWEVER DUE TO A CHANGE FROM COMPASS TO OPTIMIZE IN OUR TERRITORY, FEW RECORDS OTHER THAN INSERT SIZE ARE CURRENTLY AVAILABLE. PLEASE NOTE THAT THE SAME SIZE INSERT WAS UTILIZED. NO LOT NUMBERS ARE AVAILABLE FOR THE SAME REASON. DOI: (B)(6) 2023. DOR: (B)(6), 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture; Loss of Range of Motion

  MAUDE report 18493174 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR FLEXION CONTRACTURE. DOI: (B)(6), 2020. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 18307467 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. THE JOINT WAS WASHED OUT AND A NEW INSERT WAS PLACED. THERE WERE NO DELAYS, LOOSENING OR BROKEN INSTRUMENTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17886841 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MEDIAL COLLAPSE OF TIBIA PROSTHESES. AFTER THE TIBIA TRAY WAS REMOVED, CULTURES WERE TAKEN AND THE TIBIA WAS PREPPED FOR A REVISION TIBIAL TRAY, SLEEVE AND STEM. PATHOLOGY CALLED INTO THE ROOM AND STATED THERE WAS AN INFECTION PRESENT AND AN 16MM POLY SPACER WITH ANTIBIOTIC CEMENT WAS IMPLANTED. SURGICAL DELAY UNKNOWN. DOI: OCT 21, 2014. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17700294 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATENT WAS REVISED DUE TO POSSIBLE INFECTION OF RIGHT TKA. DOI: UNKNOWN. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17653206 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AS THE SURGEON WAS EVACUATING A HEMATOMA IN THE KNEE AND WANTED TO SWAP THE INSERT SINCE HE ENTERED THE JOINT POST OPERATION. THERE WAS NOTHING UNSTABLE IN THE KNEE AND THERE WAS NO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Hematoma

  MAUDE report 17511553 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH POLY EXCHANGE FOR POSSIBLE INFECTION. DOI: ON (B)(6) 2019, DOE: ON (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17396888 ↗

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