ATTUNE 1516-50-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 134 adverse event reports that list this exact device (DI 10603295052708), received between Jul 27, 2017 and Aug 24, 2026 — classified as 1 death, 131 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 25 most recent of 134 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a Possible infection required a poly swap. Affected side-Left.

  Patient problems: Unspecified Infection

  MAUDE report 50405712 ↗
• InjuryJul 29, 2026Migration

  It was reported that the femur is in extreme valgus.DOI: Unknown.DOR: (b)(6)2026.Affected side: Left Hip.

  Patient problems: Insufficient Information

  MAUDE report 50077233 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANT FOR SUSPECTED INFECTION 4TH OPERATION ON THIS KNEE NO WAY TO CONFIRM INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25150721 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRESENTED INFECTION WITHIN THE JOINT. PERFORMED AN I&D POLY EXCHANGE IN ATTEMPT TO REMOVE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24581670 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS INFECTED. PATIENT UNDERWENT JUST A POLY EXCHANGE. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24470334 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. LEFT TOTAL KNEE ARTHROPLASTY WAS DONE. DOI: (B)(6) 2021, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24221456 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED PAIN, LEADING THE SURGEON TO RELEASE SOFT TISSUE AND PERFORM A POLY SWAP. NO ISSUES WITH IMPLANTS. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24212917 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: AROUND 2016/2017, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23546894 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN ATTUNE RP PS CEMENTED KNEE IMPLANTED ON (B)(6) 2024. PATELLA WAS NOT RESURFACED AT THE TIME. SURGEON STATES PATIENT NOW COMPLAINS OF ANTERIOR KNEE PAIN. THE PATELLA WAS RESURFACED WITH A MEDIALIZED ANATOMIC SIZE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23425628 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION IN THE KNEE. THE SURGEON EXCHANGED SIZE 7 5MM ROTATING PLATFORM POSTERIOR STABILIZED TIBIAL INSERT. ORIGINAL IMPLANTATION DATE IS (B)(6) 2025. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23373540 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN RIGHT ATTUNE TOTAL KNEE REPLACEMENT WHICH WAS DONE (B)(6) 2024. REASON FOR REVISION IS DUE TO INFECTION. COMPONENTS WERE WELL FIXED DESPITE THE DEEP INFECTION. THE SURGEON COMMENTED HOW WELL FIXED THE TIBIAL SLEEVE WAS. ALL COMPONENTS WERE REMOVED. PATIENT HAD A UKR PREVIOUSLY WHICH WAS LOOSED, AND WAS REVISED TO THIS. DEPUY PRODUCTS WERE NOT USED IN THE UKR THE SITE WAS DEEMED AS NOT INFECTED AT THE TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22838480 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD A PRIMARY TOTAL KNEE DONE IN (B)(6) 2024. OVER TIME SINCE THE PRIMARY, SHE LOST FULL RANGE OF MOTION. SHE WAS BEING REVISED TO ADDRESS THAT. DR. REMOVED THE SIZE 7 5MM ROTATING PLATFORM PS INSERT AND THEN REMOVED SCAR TISSUE. HE THEN RE-IMPLANTED AN INSERT OF THE SAME SIZE. IT WAS A SIZE 7 ROTATING PLATFORM 5 MM INSERT. HE WAS ABLE TO REGAIN FULL RANGE OF MOTION.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 22643172 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21985864 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH I&D INSERT EXCHANGE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21892339 ↗
• InjuryApr 2, 2025Adverse 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 INFECTION AND INSERT WAS EXCHANGED. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES. THIS EVENT HAPPENED IN 2022. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21751119 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP, SUSPECTED INFECTION, NO WAY TO CONFIRM INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21652951 ↗
• InjuryMar 17, 2025Adverse 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 INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21619882 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. THERE WAS NO LOOSENING OF IMPLANTS. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 21351230 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POSSIBLE INFECTION. A POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21209316 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIBIAL BASEPLATE SUBSIDED AND RESULTED IN INSTABILITY. BASEPLATE WAS REMOVED AND REPLACED WITH ATTUNE REVISION HARDWARE. THERE WAS NO WEAR ON THE POLY. THE IMMEDIATE POST-OP FILMS OF THE IMPLANT LOOKED GOOD, THEN SHIFTED LATER. THE SURGEON FELT THEY WERE SIZED APPROPRIATELY. THERE WAS NO EXCESSIVE RESECTION OF THE FEMUR OR TIBIA IN THE PRIMARY SURGERY. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21114745 ↗
• InjuryJan 9, 2025Adverse 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 ARTHROFIBROSIS. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fibrosis

  MAUDE report 21112249 ↗
• InjuryJan 7, 2025Adverse 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 INSTABILITY. THERE WAS NO POLY WEAR. THERE WAS NO DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 21092249 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SUSPECTS LOOSENING OF THE TIBIAL BASEPLATE AS PER THE X-RAY AND A REVISION SURGERY WAS PERFORMED (B)(6) 2024 . IT WAS NOTED THAT THE CEMENT WAS WELL BONDED TO THE IMPLANT SURFACE ON THE TIBIA AND FEMORAL COMPONENTS. THE IMPLANTS SEEMED WELL FIXED, BUT WERE REMOVED DUE TO PRESENCE OF INFECTION. DOI: (B)(6) 2023, DOR:(B)(6) 2024 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20787789 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT WAS REVISED ON (B)(6) 2024, DUE TO INFECTION. DATE OF IMPLANT WAS (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20737463 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND OPENED ARTHROTOMY. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES WERE REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall

  MAUDE report 20621195 ↗