ATTUNE 1520-20-506Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295542490), received between Dec 7, 2023 and Sep 25, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50897653 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON BELIEVED THERE WAS INSTABILITY WITH FEMUR COMPONENT. THEY REMOVED FEMUR AND PLACED REVISION COMPONENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25611035 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSERT WAS REMOVED DUE TO INFECTION AND WAS REPLACED BY A NEW INSERT. NO PATIENT CONSEQUENCE. NO SURGICAL DELAY. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24023171 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS SWAPPED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23817382 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED DUE TO ANTERIOR KNEE PAIN. HER RESURFACED PATELLA COMPONENT WAS NOT TRACKING WITHIN THE TROCHLEA GROOVE OF HER FEMORAL COMPONENT. SURGEON THEREFORE CONDUCTED A LATERAL PATELLA TENDON SOFT TISSUE RELEASE, SO THE PATIENT'S PATELLA WOULD TRACK PROPERLY WITHIN THE CENTER OF THE TROCHLEA GROOVE OF HER FEMORAL COMPONENT. SURGEON ALSO REMOVED THE PATIENT'S PRIMARY TIBIAL INSERT AND REPLACED IT WAS NEW, FRESHER REPLACEMENT INSERT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 23439382 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY PATIENT CONSEQUENCE/S RELATED TO THE EVENT? NO.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23413547 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REVISED DUE TO RECURRENT INFECTION. IMPLANT FAILURE WAS NOT IN QUESTION.

  Patient problems: Unspecified Infection

  MAUDE report 22170619 ↗
• MalfunctionJan 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEBRIS WAS NOTICED ON THE MS INSERT PRIOR TO IMPLANTATION. PHYSICIAN REFUSED TO IMPLANT INSERT AND REQUESTED A NEW INSERT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. DOE: (B)(4) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105087 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED JOINT. INSERT EXCHANGED AND WASHED OUT. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20866820 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS GROSSLY INFECTED. PATIENT FELL AND SPLIT OPEN KNEE. REMOVED ALL IMPLANTS. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection; Wound Dehiscence

  MAUDE report 20844310 ↗
• InjuryJun 3, 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 UNSTABLE KNEE AND THE SURGEON UPSIZED THE POLY. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19448753 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REFERRED POST INFECTION TKA. PATIENT WAS ALSO WASHED OUT ON (B)(6) 2024 AND INSERT WAS EXCHANGED. UNFORTUNATELY THIS TREATMENT WAS UNSUCCESSFUL AND A COMPLETE REMOVAL OF HARDWARE WAS REQUIRED. SURGEON CHOSE A ONE STAGE, DUAL SET UP REVISION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS DUE TO CONSIDERABLE CONCERNS WITH THE PATIENTS SKIN AND ABILITY TO CLOSE HER. THERE WAS NO PATIENT HARM OCCURRED NOR DELAY WAS EXPERIENCED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19279400 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTED KNEE. SIMPLE POLY SWAP. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024, DOR- (B)(6) 2024, AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19214894 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD TO WASH OUT PATIENT'S KNEE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19202387 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 18281645 ↗