ATTUNE 1517-10-514Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295055945), received between Mar 24, 2020 and Jul 29, 2026 — classified as 10 injuries.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

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

  It was reported that there was a painful knee.Affected side: Right knee.

  Patient problems: Pain

  MAUDE report 50068763 ↗
• InjuryOct 31, 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 IN KNEE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20577287 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS HYPERPLASTICITY. POLY EXCHANGE WAS PERFORMED. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction

  MAUDE report 19820936 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DATE: BLANK ALERT DATE: 28-JUN-2019 COUNTRY OF EVENT: OUS PROCEDURE: TYPE OF REVISION - OPERATIVE DETAILS PART 1: FULL PROCEDURE: KNEE REVISION USING ATTUNE - OPERATIVE DETAILS PART 2: PS RP OPERATIVE SIDE: LEFT DATE OF SURGERY: (B)(6) 2019 EVENT DESCRIPTION (DIAGNOSIS): OPERATIVE WOUND DEHISCED CENTRAL 8CMS: FURTHER REVISION SURGERY REQUIRED UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR OPERATIVE WOUND DEHISCED CENTRAL 8CMS: WOUND DEHISCENCE REQUIRING DAIR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2019 DATE OF EVENT: 26 JUN 2019 (LEFT KNEE) TREATMENT: IRRIGATION & DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19645800 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE WAS EXPLANTED DUE TO INFECTION. NO ONE MENTIONED ANY PROBLEMS WITH OUR IMPLANTS. SURGEON REPLACED WITH ANTIBIOTIC SPACER. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18697522 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ONLY A FEW WEEKS OUT FROM REVISION SURGERY. DURING RECENT PT, SHE DEHISCED HER ARTHROTOMY CLOSURE. HER KNEE WAS BEING IRRIGATED AND DEBRIDED AND A POLY EXCHANGE WAS PERFORMED. AS WELL AS A REPAIR OF HER PATELLAR TENDON. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 14021827 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY EXCHANGE AT THE RIGHT KNEE ARTHROTOMY WITH BONE SPUR REMOVAL FOR INCREASED RANGE OF MOTION. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 13790473 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CORTISONE INJECTION TO THE LEFT KNEE ON (B)(6) 2020. ON (B)(6) 2020 MEDICAL RECORDS NOTE THE PATIENT PRESENTS WITH BILATERAL KNEE PAIN. UPDATED ASSESSMENT NOTED LEFT KNEE STATUS POST REVISION KNEE ARTHROPLASTY FOR LOOSE COMPONENT WITH A SECONDARY HISTORY OF PES ANSERINE BURSITIS TREATED WITH A CORTISONE INJECTION WITH GOOD RESULTS. DOI: (B)(6) 2014. DOR: (B)(6) 2019 (TIBIA, FEMUR AND INSERT - CAPTURED IN (B)(4)). DOE: (B)(6) 2020; LEFT KNEE.

  Patient problems: Inflammation; Pain

  MAUDE report 11444266 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE SURGEON CONDUCTED AN I&D AND CHANGED THE POLY. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11245687 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED RIGHT TOTAL KNEE. INCISION AND DEBRIDEMENT. POLY EXCHANGE WAS PERFORMED. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9872297 ↗