ATTUNE 1516-20-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295045779), received between Jul 14, 2017 and May 15, 2026 — classified as 43 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 51 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 PATIENT EXPRESSED DISCOMFORT AND PAIN IN THE TIBIA. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 25190985 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: CAN YOU PLEASE PROVIDE THE IMPLANT AND EXPLANT DATE. UNKNOWN IMPLANT DATE. EXPLANT DATE WAS (B)(6) 2026. WHAT IS THE EXACT ALLEGATION OF THE REPORTED PRODUCT? MAL-ALIGNMENT. IS THIS SURGEON ERROR DURING THE PRIMARY IMPLANTATION PROCEDURE? YES.

  Patient problems: Pain

  MAUDE report 25047768 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO POLY SWAP. AFFECTED SIDE: RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 24909555 ↗
• MalfunctionMar 4, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS A BLACK HAIR FIRMLY STICKING TO THE INSERT INSIDE THE STERILE PACKAGE. SEEN UPON OPENING THE INNER STERILE PACKAGE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511841 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION STATES THAT THE PATIENT APPROACHED THE SURGEON REQUESTING GREATER FLEXION RANGE TO ALLOW FOR THEIR CYCLING.

  Patient problems: Loss of Range of Motion

  MAUDE report 24283990 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS KNEE WAS REVISED FOR PATELLA PAIN. DOCTOR RESECTED SOME UNCOVERED BONE AND EXCHANGED THE INSERT. ORIGINAL DATE OF SURGERY WAS UNKNOWN, BUT MENTIONED 2014. DOI: 2014. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24221528 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT LACKED RANGE OF MOTION. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 23942903 ↗
• InjuryDec 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 PAIN. IMPLANT DATE UNKNOWN.

  Patient problems: Pain

  MAUDE report 23813580 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE SURGEON HAD TO OPEN ANOTHER INSERT AS THE INSERT THEY OPENED INITIALLY WOULD NOT SEAT ON THE TIBIA IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751751 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME TIGHT. SURGEON PERFORMED SOFT TISSUE RELEASE AND PERFORMED A POLY SWAP AS THE JOINT WAS OPEN ANYWAYS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Muscular Rigidity

  MAUDE report 23381404 ↗
• MalfunctionAug 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE HOSPITAL HAD FAULTY INSERT AND HAD TO USE ANOTHER. THE DEVICE WAS WORN DUE TO WEAR AND TEAR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803422 ↗
• MalfunctionAug 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ANTERIOR LOCKING TAB DIDN'T PROPERLY SECURE, INSERT NEVER FULLY ENGAGED WITH TRAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795604 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WASH OUT AND REVISED WITH POLY EXCHANGE DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22009939 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT HAD RIGHT KNEE POLY SWAP DUE TO INFECTION. IMPLANT AND EXPLANT DATES UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20750864 ↗
• InjuryJul 25, 2024Naturally Worn; Naturally Worn

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO LOOSENING (UNKNOWN COMPONENT(S) OR INTERFACE) AND PAIN. AT REVISION THE TIBIAL INSERT SHOWED MINOR YELLOWING.

  Patient problems: Pain

  MAUDE report 19830307 ↗
• InjuryJul 16, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Insufficient Information

  MAUDE report 19753473 ↗
• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REMOVAL OF TOTAL KNEE FOR SEPSIS, IMPLANT ANTIBIOTIC SPACER. DOI- UNKNOWN; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19079874 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED LEFT KNEE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18357311 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO JOINT INFECTION. A WASH OUT WAS DONE AND A SAME SIZE POLY SZ6 - 6MM CRFB WAS INSERTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17780185 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED REVISION OF ATTUNE TKA IMPLANTS. PATIENT HAD RECEIVED PRIMARY IMPLANTS (B)(6) 2020. SOON AFTER COMPLAINED OF PAIN. PAIN GOT PROGRESSIVELY WORSE OVER TIME. HEAT SIGNATURE SCANS REVEALED POTENTIAL PATELLA LOOSENING BUT NOT CONCLUSIVE. ALL CULTURE FOR INFECTION WERE NEGATIVE. DUE TO INCREASING PAIN AND POTENTIAL HEAT SIGNATURE, DECISION WAS MADE TO REVISE THE JOINT REPLACEMENT USING ATTUNE REVISION. DOI: AUG 16, 2020. DOE: (B)(6), 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17642664 ↗
• MalfunctionJan 24, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO INSERT TIBIAL BEARING CAREFULLY USING THE PROPER STEPS. AFTER SEVERAL ATTEMPTS, THEY OPENED A NEW BEARING AND REPEATED THE INSERTION STEPS AND THE INSERT SEATED PROPERLY. THERE WAS A 4 MINUTE OF SURGICAL DELAY REPORTED. DOE: (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 16232997 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. A POLY WASHOUT AND AN EXCHANGE WERE DONE. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15562350 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SURGERY FOR FRONT KNEE PAIN. SURGEON RESURFACED BOTH PATELLAS AS THEY WERE NOT RESURFACED DURING THE ORIGINAL SURGERY IN 2016. SURGEON ALSO EXTRACTED THE ATTUNE CVD SIZE 6 AND SIZE 5 INSERT DURING THE CASE. NEW ATTUNE CURVED INSERTS MATCHING THE ORIGINAL SIZES WERE IMPLANTED. NO DELAY IN SURGERY. NO INJURY TO PATIENT. ORIGINAL SURGERY DATE WAS (B)(6) 2016. THIS WAS BILATERAL KNEE SURGERY.

  Patient problems: Pain

  MAUDE report 12330838 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. ALL COMPONENTS WERE REMOVED. DOI: (B)(6) 2017, DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12288767 ↗
• InjuryJul 29, 2021Adverse 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 SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2021 (RIGHT KNEE). TREATMENT: REVISION OF FEMORAL, TIBIAL AND INSERT COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 12245465 ↗