ATTUNE 1517-10-820Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295056300), received between Jun 29, 2020 and Oct 15, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION LTKA BACK ON (B)(6) 2024 BY SURGEON. PATIENT FELL AND SPLIT OPEN HER INCISION. DR. REMOVED ATTUNE REVISION POLY AND EXCHANGED WITH A NEW ONE ALONG WITH PERFORMING A WASHOUT AND SOFT TISSUE REPAIR. THE POLY HAD ALSO SPUN AROUND FROM THE FALL. ATTUNE REVISION INSERT HAD TURNED SIDEWAYS. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 20451565 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16213884 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. THE SURGEON PERFORMED AN I AND D. THE POLY WAS SWAPPED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16023863 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2019, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10460639 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. PATIENT HAD A RT TKA REVISION ON (B)(6) 2019, AND THEN HAD ANOTHER REVISION WITH POLY CHANGE ON (B)(6) 2019 EXCHANGING A PS RP INSERT FOR A CRS INSERT (MDR CASE NUMBER (B)(4)). THE SURGEON WANTED TO REMOVE THE SIZE 8 CRS FEMUR AND PUT IN EITHER A SIZE 9 OR 10 TO LOSE THE FLEXION GAP. THE SURGEON REMOVED THE FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM STAYED IN THE FEMUR. THE SURGEON THEN TRIALED USING A SIZE 9 AND 10 FEMUR TO CLOSE THE FLEXION GAP. THE SURGEON FELT THAT THE SIZE 10 FEMUR WOULD BE THE BEST OPTION. IMPLANTS WERE OPEN ALONG WITH AUGMENTS. THE SURGEON CEMENTED THE FEMORAL COMPONENT IN PLACE AND FELT LIKE A SIZE 10 CRS 20 MM INSERT GAVE THE BEST STABILITY IN EXTENSION AND FLEXION. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10206839 ↗