ATTUNE 1516-20-905Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295046127), received between Dec 19, 2019 and May 7, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 21979111 ↗
• MalfunctionOct 23, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WOULDN'T SIT ALL THE WAY, HAD A LITTLE BIT OF LIFT. DOE: (B)(6), 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985327 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT 'S BILATERAL KNEES WERE DONE. FIRST CASE WAS DONE BACK IN MAY 24,2022. SECOND CASE WAS (B)(6) 2022: PATIENT HAD ACUTE PERIPROSTHETIC JOINT INFECTION. MS INSERTS REPLACED BOTH. DOI:(B)(6) 2022. DOR:(B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16941147 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 15.3 MONTHS. REASON FOR REVISION: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16362575 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT KNEE INFECTION. IMPLANTS REMOVED AND TEMPORARY ABX SPACER WAS IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 15868843 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

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

  MAUDE report 12440991 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASES (B)(4) REPORT: PATIENT HAD A LEFT TKA DONE ON (B)(6) 2021. THE SURGEON TOLD ME HE TESTED THE PATIENT FOR INFECTION AND IT CAME BACK POSITIVE. HE WANTED TO REMOVE THE POLY AND DO A WASHOUT. HE REMOVED THE POLY WITH NO PROBLEM, WASHED OUT THE JOINT, AND PLACED A NEW INSERT INTO THE PATIENT AND CLOSED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 12438284 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A POLYSWAP PROCEDURE WAS DONE. NO SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12099839 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTENDED ATTUNE POLY EXCHANGE FOR INFECTION LEFT TKR. BILATERAL TKR INSITU FROM APPROX 1 YR AGO. PT SUSTAINED LOCALIZED INFECTION DUE TO SKIN ABRASION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Laceration(s)

  MAUDE report 11163678 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6); ASPIRATION DONE TO CONFIRM INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10397497 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL STIFF KNEE AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT MANUFACTURER WAS USED. DOI: (B)(6) 2015, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9578391 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 25 NOV 2019. MEDICAL RECORDS RECEIVED ON 25 NOVEMBER 2019 WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES ON 16 DECEMBER 2019. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND UNKNOWN BONE CEMENT. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, SWELLING AND PAIN. THE SURGEON REPORTED A PATELLOPLASTY WAS ALSO PERFORMED WITH THE REMOVAL OF BONE SPURS. HE NOTED THE PATELLAR COMPONENT WAS WELL FIXED AND WELL POSITIONED AND WAS DEBRIDED. THE SURGEON REPORTED A SYNOVECTOMY OF SOME TISSUE THAT WAS CONSISTENT WITH OSTEOLYSIS. HE INDICATED THE FEMORAL COMPONENT APPEARED LOOSE WITH MOTION AND SOME AREAS DID NOT RETAIN MUCH CEMENT. THE SURGEON REPORTED THE TIBIAL COMPONENT HAD MOTION BETWEEN THE COMPONENT MEDIALLY ANT THE BONE. BOTH THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED, AND THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDUR

  Patient problems: Edema; No Code Available; Osteolysis; Pain

  MAUDE report 9564163 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS TIGHTNESS IN FLEXION AND EXTENSION, MORE FEMORAL BONE WAS RESECTED.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9498136 ↗