ATTUNE 1517-10-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295055792), received between Jul 25, 2019 and Aug 19, 2026 — classified as 16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain.DOI: (b)(6) 2025.DOR: (b)(6) 2026.Affected Side: Left.

  Patient problems: Pain

  MAUDE report 50329002 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTED TOTAL KNEE. I&D WAS PERFORMED WITH POLY INSERT EXCHANGE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21294147 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY VIA TKA. AFTER THE SURGERY, INFECTION OCCURRED, AND A REVISION TKA WAS PERFORMED. DURING THE REVISION SURGERY, UNKNOWN DEFECT OCCURRED. WE ARE CONFIRMING ABOUT DETAILS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IT IS UNKNOWN WHETHER THE PRODUCTS USED IN THE INITIAL SURGERY WERE J&J¿S PRODUCTS OR NOT. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL EVENT INFORMATION DURING THE REVISION SURGERY, THE ATTUNE TIBIAL TRIAL EXTRACTOR BROKE OFF. THE BROKEN EXTRACTOR WAS REMOVED BY AN ELEVATOR, AND THE REVISION SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. IT IS BELIEVED THAT THERE ARE NO REMAINS OF DAMAGED FRAGMENTS IN THE BODY, BUT BECAUSE OF THE NON-METALLIC NATURE OF THE FRAGMENTS, THEY COULD NOT BE CONFIRMED BY X-RAYS.

  Patient problems: Unspecified Infection

  MAUDE report 20321189 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Unspecified Infection

  MAUDE report 20300937 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TKA. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 19940371 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DEBRIDEMENT AND IRRIGATION WITH NEW POLY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19165214 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. AFTER THE SURGERY, THE PATIENT FELL AND HAD A PERIPROSTHETIC FEMORAL IMPLANT FRACTURE. THE REVISION SURGERY IS SCHEDULED ON AN UNKNOWN DATE TO FIX THE AFFECTED AREA WITH PLATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 17574240 ↗
• InjuryJan 3, 2023Naturally Worn; Naturally Worn

  PATIENT HAD PRIMARY SURGERY IN 2013 - IMPLANT STICKERS ATTACHED. IN 2022, TIBIA LOOSE AND JOINT UNSTABLE AND LAX. REVISION OF BOTH COMPONENTS TODAY AT (B)(6) HOSPITAL. SURGEON COMMENTED THAT ¿PITTING WAS EVIDENT¿. PRE-OP X-RAYS ALSO ATTACHED. DOI: 2013. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16086901 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH STIFF, LIMITED ROM, I&D AND POLY EXCHANGE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 15983802 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED FIRST STAGE RIGHT TOTAL KNEE REVISION FOR A FUNGAL INFECTION OF THE RIGHT KNEE. PT ALREADY HAD IN SITU ATTUNE REVISION IMPLANTS, REQUIRING FULL EXTRACTION OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 15493792 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI : UNKNOWN, DOR : (B)(6) 2021 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12781001 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12569708 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY WAS EXCHANGED FOR A NEW ONE. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12546669 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION IN KNEE. AN I&D WAS DONE. DOI: (B)(6) 2019 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11486061 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS REDNESS AND SUSPECTED INFECTION. I&D WITH POLY EXCHANGE WITH REPLACEMENT OF ANTIBIOTIC BEADS. NO RECORDS AVAILABLE ON CEMENT AS IT WAS IN HOSPITAL INVENTORY. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10601811 ↗
• MalfunctionMar 4, 2020Difficult to Insert; Difficult to Insert

  SURGERY WAS DELAYED FOR ABOUT 10-15 MINS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9788307 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED I&D POLY EXCHANGE WAS DONE. PROTEUS BACTERIUM. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8825965 ↗