ATTUNE 1516-50-907Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295053002), received between Dec 19, 2019 and Apr 17, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD AN UNSTABLE KNEE; SURGEON EXPLANTED POLY REVISING WITH THICKER POLY. DOI: UNKNOWN, DOR:(B)(6) 2026, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24911204 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SHOWED SIGNS OF INFECTION. THE SURGEON DID A WASHOUT AND POLY SWAP. THERE WERE NO SIGNS OF PROBLEMS WITH IMPLANTS OR EXTENDED TIME DUE TO THE IMPLANTS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21733619 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: HOSPITALIZATION (INITIAL OR PROLONGED): YES:NO. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: NO: YES.

  Patient problems: Abscess

  MAUDE report 20831750 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FAILED ORTHOPEDIC IMPLANT. 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: (B)(6) 2023 (RIGHT KNEE). TREATMENT: REVISION; LINER WAS REVISED AND PATELLA WAS RESURFACED DEPUY PRODUCTS USED (NO REVISION COMPLETED).

  Patient problems: Insufficient Information

  MAUDE report 17913752 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PALPABLE SCARRING THAT CATCHES OVER THE SUPERIOR ASPECT OF THE ARTHROTOMY INCISION OF THE RIGHT KNEE EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6). DATE OF EVENT: (B)(6). (RIGHT KNEE). TREATMENT: PRESCRIPTION VOLTAREN GEL.

  Patient problems: Scar Tissue

  MAUDE report 17904232 ↗
• InjurySep 1, 2023Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  REVISION OF INSERT WAS PERFORMED TO TREAT SPIN OUT. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 17669337 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. ALL IMPLANTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17395644 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TKA ON (B)(6) 2023. HE WAS ADMITTED TO THE HOSPITAL FOR SWELLING AND A LEFT KNEE INFECTION. DURING THE WORK UP IT WAS NOTED ON THE X-RAY THAT THERE WAS A RIGHT KNEE FEMORAL IMPLANT ON THE LEFT FEMUR. THE PATIENT WAS BROUGHT TO SURGERY AND THE FEMUR WAS REMOVED AND A ATTUNE REVISION IMPLANT WAS PLACED. THE KNEE WAS DEBRIDED AND A SINGLE STAGE RE IMPLANT WAS DONE. THERE WAS NO LOOSENING, OR BROKEN INSTRUMENTS. THE CEMENT MANUFACTURER WAS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16591461 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 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 2.8 MONTHS. REASON FOR REVISION: INFECTION

  Patient problems: Unspecified Infection

  MAUDE report 16363311 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS INFECTED SO THE SURGEON DECIDED TO REMOVE THEIR IMPLANTS AND PUT IN A CEMENT SPACER. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15561575 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON BELIEVED THAT THE PATIENT KNEE WAS INFECTED AFTER SEEING THE PATIENT IN OFFICE. SURGEON DECIDED TO BRING THE PATIENT TO SURGERY AND DO A WASHOUT AND POLY SWAP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15469872 ↗
• InjuryMay 16, 2022Adverse 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 PAIN. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14406825 ↗
• InjuryJan 14, 2022Adverse 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) 2022. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13257652 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A RECURRING INFECTION. THE INSERT WAS REMOVED AND NO NEW INSERT WAS IMPLANTED AFTER I&D. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11594924 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS VALGUS TIBIAL MALALIGNMENT. WELL FIXED PRIMARY ATTUNE TIBIA WAS REMOVED AND REPLACED WITH A RP REVISION TIBIA AND PRESSFIT SLEEVE AND STEM. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11387516 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND LOOSENING OF AN UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENTS WERE USED. THE PATIENT HAD HIS PATELLA RESURFACED NO SURGICAL DELAY. DOI: (B)(6) 2017; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Osteolysis

  MAUDE report 11295832 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO COMPLAINING OF LATERAL PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11293645 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE AND VALGUS. THE PATELLA WAS 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) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, LACK OF MOTION, FUSIONS, AND PAIN. THE SURGEON REPORTED THE TIBIA HAD BONE THAT HAD GROWN UP AROUND THE TIBIAL TRAY AS IF THE BODY WAS TRYING TO STABILIZE A LOOSE IMPLANT. THE TIBIAL TRAY WAS EASILY REMOVED AND HAD NO CEMENT ADHERENT AT THE TRAY TO CEMENT INTERFACE. THE CEMENT WAS WELL-FIXED TO THE BONE. THE FEMORAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. THE SURGEON INDICATED THE PATELLA WAS REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY REVISION KNEE SYSTEM. COMPETITOR¿S CEMENT WAS UTILIZED, AND THERE WERE NO COMPLICATIONS REPORTED. DOI: (B)(6) 2017. DOR: (B)(6) 2019, (LT KNEE).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9496714 ↗