ATTUNE 1516-40-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295050100), received between Oct 10, 2017 and May 15, 2026 — classified as 42 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I&D WITH POLY EXCHANGE FOR INFECTED LEFT TOTAL KNEE. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25189717 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIZE 6 10MM PS FB INSERT WAS REMOVED DUE TO INFECTION. NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCE. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24166845 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A WASHOUT OF A POSSIBLE INFECTED KNEE, AND THERE WAS POLY EXCHANGE. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23942992 ↗
• InjuryNov 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 INSTABILITY AND CHOSE NOT TO TRIAL A DIFFERENT SIZE INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23631594 ↗
• InjuryOct 27, 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 THAT APPEARED TO BE OCCURRING FOR A WHILE. SURGEON DECIDED TO REMOVE IMPLANTS IMPLANT AN ANTIBIOTIC SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23393681 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLYETHYLENE INSERT EXCHANGED DUE TO INFECTION. EXCHANGED FOR NEW INSERT. NO KNOWN COMPLAINTS FROM PATIENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23009216 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6), CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE INSTABILITY, DEVICE AND PROCEDURE (RELATEDNESS) , DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: DEFINITELY RELATED, DATE OF EVENT: 25 JUL 2015, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: (B)(6) 2016, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: SURGICAL TREATMENT OF STUDY KNEE, SPACER REVISION DOCUMENTATION DOES NOT MENTION REMOVAL OF ANY COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 22344419 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL WHICH LED TO INSTABILITY. INCREASED POLY THICKNESS. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21026051 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR EXCHANGED THE POLY DUE TO A CONFIRMED INFECTION WITHIN JOINT CAPSULE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19304919 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PT RETURNED TO SURGERY FOR PATELLAR DEBRIDEMENT AND ALIGNMENT AFTER TKS. THE INSERT WAS REPLACED DURING THE PROCEDURE AND A 12MM INSET WAS PLACED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME: NO INFECTION, NO LOOSENING, NO DELAY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: NO, ACTIVITY LEVEL: AVERAGE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST: TRUE.

  Patient problems: Joint Laxity

  MAUDE report 17903931 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED TIGHTNESS IN EXTENSION AND FLEXION. SURGEON DOWNSIZED THE TIBIAL INSERT. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17732366 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 17116607 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 17079269 ↗
• MalfunctionApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS REPORTED FOR UNKNOWN REASON. DOI: UNKNOWN. DOR: FEBRUARY 24, 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16805743 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16386450 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RANGE OF MOTION. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 16270990 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED THAT THE PATIENT DID NOT DO THEIR REHAB AND WAS NOT GETTING FULL EXTENSION OR FLEXION PAST 40 DEGREES. SURGEON DEBRIDED THE KNEE AND PUT IN A 6MM POLY. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 15494375 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2022. DIR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15216614 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO LOOSENING REPORTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6)2022. DOR; (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14985777 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS NOT INDICATED. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14914232 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRESENTED WITH PAIN AND NO IMPLANT APPEARED LOOSE. THE IMPLANT WAS SOMEWHAT UNSTABLE. DOI: 2015, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12705426 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO WAS NEVER ABLE TO GET FULL EXTENSION AND WAS ALSO TIGHT IN FLEXION. SURGEON WANTED TO GO IN AND DO A POLY EXCHANGE. SURGEON PUT IN A THINNER INSERT AND REMOVED THE POLY. TRIALED A THINNER INSERT AND WAS HAPPY WITH THE PATIENTS FLEXION & EXTENSION. SURGEON PERFORMED A RT TKA ON THIS PATIENT LAST (B)(6). DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion

  MAUDE report 11841668 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 02 FEB 2021 WAS REVIEWED. ON (B)(6) 2016, THE PATIENT HAD A CONVERSION FROM UNI-COMPARTMENTAL ARTHROPLASTY OF THE RIGHT KNEE TO TOTAL KNEE ARTHROPLASTY. INDICATIONS FOR SURGERY INCLUDED PAIN. DURING THE PROCEDURE THE KNEE JOINT REVEALED SEVERE TRICOMPARTMENTAL ARTHRITIC CHANGES AND UNI-COMPARTMENTAL MEDIALLY THERE WAS LOOSENING. DEPUY COMPONENTS INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. THERE WAS NO MENTION OF THE MANUFACTURER OF THE PREVIOUSLY IMPLANTED UNI. ON (B)(6) 2017, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO RIGHT INFECTED TOTAL KNEE. ALL COMPONENTS INCLUDING THE PATELLA WERE REVISED. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING DEPUY CEMENT X3. DOI: (B)(6) 2016. DOR: (B)(6) 2017 (RIGHT KNEE).

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

  MAUDE report 11413537 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT SEVERE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE TIBIAL INSERT EXCHANGE. THE PATIENT WAS EXPERIENCING PAIN, DECREASED RANGE OF MOTION, ARTHROFIBROSIS, AND ADHESIONS. THE SURGEON NOTED LYSIS OF EXTENSIVE ADHESIONS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2016 LEFT KNEE TIBIAL INSERT.

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

  MAUDE report 11373717 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MID-FLEXION INSTABILITY. A REVISION TO AN ATTUNE FULL REVISION WAS PERFORMED. DOI: (B)(6) 2017; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11174012 ↗

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