ATTUNE 1516-40-605Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10603295050063), received between Sep 22, 2017 and Aug 7, 2026 — classified as 101 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (13 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 120 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Joint Laxity; Pain

  MAUDE report 50173475 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient underwent an I&D due to suspected infection.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50090781 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE FOR INFECTION TOOK PLACE. NO HARM; NO DELAYS; NO BROKEN INSTRUMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24210266 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DPO_10004_10008. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE CONTRACTURE S/P TKA, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY RELATED, PROCEDURE RELATED: POSSIBLY RELATED, DATE OF EVENT: 02 JUL 2014, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, MANIPULATION UNDER ANESTHESIA. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 151640605, LOT NUMBER ID: 337790, COMPONENT: INSERT, DESCRIPTION: ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING POSTERIOR STABILIZED 6 5MM AOX.

  Patient problems: Septic loosening

  MAUDE report 24079798 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STAGE 1 KNEE REVISION WAS PERFORMED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23983273 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM PAIN. ALL AVAILABLE INFORMATION WAS DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23854347 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FEMUR WAS REVISED DUE TO TIGHT IN EXTENSION. THERE WAS NO DELAY, ALL PIECES RETRIEVED, NO ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 23789524 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY EXCHANGE FOR I&D FOR INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23088000 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF KNEE PAIN, AND DOCTOR REMOVED EXISTING POLY AND PUT IN NEW POLY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 23041729 ↗
• InjurySep 11, 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 INSTABILITY. SURGEON IMPLANTED ON (B)(6) 2022 AT ANOTHER FACILITY. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23031681 ↗
• MalfunctionSep 11, 2025Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE INSERT DID NOT FIT IN THE TIBIAL BASE BECAUSE ONE OF THE FINS WAS BENT. SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT. ANOTHER IMPLANT WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024723 ↗
• 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 DUE TO INFECTED KNEE. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22519625 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN AND INSTABILITY. INSTABILITY WAS NOT RELATED TO POLY WEAR. NO REPORTED MALPOSITION OF COMPONENTS. INSERT MAY HAVE BEEN UNDERSIZED, WENT TO A 12 MM INSERT IN THE REVISION. JOINT LINE NOT RAISED IN PRIMARY SURGERY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21462671 ↗
• InjuryJan 8, 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 PAIN WITH SUSPECTED LOOSE COMPONENTS. SURGICAL DELAY WAS UNKNOWN. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21102462 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A STAGE 1 KNEE REVISION TO RULE OUT INFECTION. THERE WAS NO SURGICAL DELAY, AND NO SECOND STAGE REVISION WAS PERFORMED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20745483 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A TOTAL KNEE REPLACEMENT SURGERY ON AN UNKNOWN DATE. THE PATIENT WAS REVISED DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20693346 ↗
• MalfunctionNov 14, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE KNEE JOINT SURGERY, THE SURGEON COULD NOT INSTALL THE INSERT, AND IT IS SUSPECTED THAT THERE WAS A PRODUCT THICKNESS ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681968 ↗
• InjuryNov 7, 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 KNEE PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20631669 ↗
• MalfunctionNov 1, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE INSERT COULD NOT BE LOCKED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586411 ↗
• MalfunctionOct 29, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY WITH THE IMPACTION OF A FIXED ATTUNE PS INSERT. HE HAD TO STERILIZE TWO INSERTS BEFORE HE COULD FINALLY PUT HIS INSERT IN CORRECTLY. POSE FAILURE AND CLICKING PROBLEM WITH THE DEVICE. ADDITIONAL EVENT INFORMATION: THE DEVICE DID NOT CLIP INTO THE TIBIA AND THAT FOR THE TWO IMPLANTS INVOLVED. THE SURGERY WAS DELAYED 15 TO 20 MINUTES WITHOUT IMMEDIATE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556238 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LEFT KNEE REVISION OCCURRED ON (B)(6) 2024 WHERE AN I&D/POLY SWAP WAS PERFORMED DUE TO SURGEON'S SUSPICION OF INFECTION. IT IS UNKNOWN IF INFECTION WAS PRESENT. ORIGINAL IMPLANT WAS (B)(6) 2024

  Patient problems: Unspecified Infection

  MAUDE report 20522200 ↗
• MalfunctionOct 10, 2024Difficult to Insert; Difficult to Insert

  WHAT WAS THE EXACT ALLEGATION AGAINST THE DEVICE? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION? IT DID NOT CLIP INTO THE TIBIA AND THAT FOR THE TWO IMPLANTS INVOLVED. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? 15 TO 20 MINUTES. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO IMMEDIATE PATIENT CONSEQUENCE. THE SURGEON NOTIFIED THE FACT OF SEEING THE SECONDARY EVOLUTION OF THE PATIENT.

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

  MAUDE report 20419570 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED A THICKER POLY. DOI: (B)(6) 2019 DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20258545 ↗
• InjuryAug 27, 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 PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20077425 ↗
• MalfunctionJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ATTUNE IMPLANTS DUE TO LOOSENING. ATTUNE TIBIAL TRAY WAS CLEAN OF CEMENT UPON REMOVAL. ATTUNE REVISION SURGERY COMPLETED.

  Patient problems: Pain

  MAUDE report 19615212 ↗

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