ATTUNE 1516-20-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295045564), received between Jan 22, 2018 and Jun 4, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO AN INJURY THAT RESULTED IN MCL INSTABILITY REQUIRING A MORE CONSTRAINED PROSTHESIS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 25391383 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT KNEE REVISION ON (B)(6) 2024. A POLY SWAP WITH NO SURGICAL DELAY RELATED TO THE EVENT. THE REASON FOR THE REVISION WAS DUE TO THE PATIENT BEING LOOSE MEDIALLY IN FLEXION OF THE KNEE. THE SURGEON DECIDED TO SWAP OUT THE CR FB INSERT FOR A MS FB INSERT. HE ALSO PUT AN ARTHREX INTERNAL MCL BRACE IN THE PATIENT. DATE OF IMPLANT WAS (B)(6) 2024. THE INSTABILITY WAS NOT RELATED TO POLYETHYLENE WEAR. THERE WAS NO REPORTED MALPOSITION OF THE COMPONENTS THAT LED TO THE INSTABILITY. THE COMPONENTS WERE NOT UNDERSIZED. THERE WAS NO EXCESSIVE RESECTIONS OF THE FEMUR OR TIBIA THAT LED TO THE INSTABILITY AND THE JOINT LINE WAS NOT CHANGED THAT LED TO THE INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 20654629 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSE IN EXTENSION. GOING UP IN POLY THICKNESS. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18085236 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY/LIGAMENTOUS LAXITY. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: TIBIAL INSERT REVISED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11870063 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPON EXAMINATION, THE DOCTOR SUGGESTED A POLY EXCHANGE TO A THICKER POLY. A BONE SCAN WAS PERFORMED AND THERE WERE NO SIGNS OF IMPLANT LOOSENING. THE 10MM POLY WAS REMOVED AND REPLACED WITH A 16MM POLY. IT WAS SHOWN TO MAKE THE KNEE VERY STABLE WITH A FULL RANGE OF MOTION FROM FLEXION TO EXTENSION. DOI: (B)(6) 2019; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11498896 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS A LOOSE KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9555397 ↗
• InjuryNov 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 14 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO SEVERE OSTEOARTHRITIS AND PAIN. THE PATELLA WAS NOT RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO SUBLUXATION, POSTERIOR KNEE DISLOCATION. THE SURGEON NOTED THE PCL AND MCL WERE DISRUPTED, THOUGH A SLEEVE OF MEDIAL TISSUE WAS INTACT, AND THE LATERAL STRUCTURES WERE INTACT. HE NOTED A WELL-FIXED FEMORAL COMPONENT THOUGH REVISED. THE SURGEON NOTED THE TIBIAL COMPONENT WAS EASILY DISIMPACTED FROM THE CEMENT MANTLE. HE INDICATED THE PATELLA WAS TOO THIN TO ACCEPT A NEW PATELLAR COMPONENT. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND DEPUY CEMENT X 2. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2017, DOR: (B)(4) 2017, (RT KNEE).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9285933 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, INSTABILITY, METAL ALLERGY, ARTHROFIBROSIS, STIFFNESS, AND ADHESIONS. THE SURGEON INDICATED ASEPTIC LOOSENING AS ONE OF THE POST-OPERATIVE DIAGNOSES, HOWEVER, THERE IS NO MENTION OF LOOSENING WITHIN THE REVISION OPERATIVE PROCEDURE NOTE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Adhesion(s); Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9273425 ↗
• InjuryAug 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7776353 ↗
• InjuryJan 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT KNEE POSSIBLE INFECTION WITH POLY SWAP. DOI: (B)(6) 2017; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7208969 ↗