ATTUNE 1516-50-506Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10603295052432), received between Jun 29, 2018 and Sep 29, 2026 — classified as 96 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 98 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50933068 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had painful right knee.Affected Side: Right.

  Patient problems: Pain

  MAUDE report 50453046 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent poly swap due to infection. DOI: Unknown. DOR: (b)(6) 2026.Affected side: Right knee.

  Patient problems: Unspecified Infection

  MAUDE report 50055118 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED, DID A POLY SWAP. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25135176 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT KNEE WAS INFECTED, NO DELAY IN CASE, POLY SWAP. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24884265 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD KNEE INSTABILITY ISSUES. IT WAS RESOLVED WITH A THICKER POLY. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24833932 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ATTUNE PRIMARY PS RP KNEE CURRENTLY IN. THEY WERE BEING REVISED BECAUSE THEIR KNEE WAS STIFF AND DID NOT HAVE FULL RANGE OPTION. THE DOCTOR REMOVED SCAR TISSUE AND REMOVED THE SIZE 5 - 6MM INSERT AND IMPLANTED A SIZE 5 - 5MM INSERT. AFFECTED SIDE: RIGHT.

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

  MAUDE report 24482815 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED INSERT FOR INSTABILITY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24303925 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN. DOI: (B)(6) 2025. DOR:(B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23789451 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) 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 "ARTHROFIBROSIS".

  Patient problems: Adhesion(s); Arthrofibrosis

  MAUDE report 23464567 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WAS A DAIR OF AN ATTUNE PSRP CONSTRUCT FOR INFECTION, ON THE PATIENT'S RIGHT SIDE. THE TIBIAL INSERT WAS REMOVED, AND THE SITE WAS THOROUGHLY CLEANED AND DEBRIDED. A NEW INSERT WAS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22530023 ↗
• InjuryMay 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 FOR STIFFNESS AND PAIN. ALL COMPONENTS WERE WELL FIXED AND WELL POSITIONED. SURGEON EXCISED ALL SCAR TISSUE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain

  MAUDE report 21997784 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN. DOCTOR SAID CT SHOWED THAT THE FEMORAL COMPONENT WAS LOOSE. THE SURGEON CHECKED THE FEMORAL AND TIBIAL COMPONENTS BUT BOTH SEEMED TO BE STABLE. HE DECIDED TO REMOVE THE FEMORAL COMP THINKING IT MIGHT BE INFECTED. HE SENT CULTURES AND EVERYTHING WAS CLEAR FOR INFECTION. HE REPLACED THE FEMORAL WITH A CRS IMPLANT WITH SLEEVE AND STEM. THE APPROPRIATE SIZE POLY FOR RANGE OF MOTION WAS IMPLANTED. TIME WAS NOT EXTENDED IN SURGERY AND NOTHING WAS MENTIONED ABOUT BEING LOOSE OR A PROBLEM WITH OUR IMPLANTS. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21925847 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED FOR INSTABILITY. NO HARM TO PATIENT. NO DELAYS. NO BROKEN INSTRUMENTS. DOI- (B)(6) 2019 DOR- (B)(6) 2024 AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21113186 ↗
• InjuryJan 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO GLOBAL TIGHTNESS AND ADHESIONS. POLY WAS EXCHANGED. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 21051842 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND UNDERWENT LINER EXCHANGE TO RULE OUT INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20798338 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LEFT KNEE REVISION OCCURRED ON (B)(6) 2024 DUE TO PAINFUL KNEE. REVISED TIBIAL COMPONENT. BONE SCAN SHOWED LOOSENING BUT THE SURGEON SAID IT DIDN'T SEEM LOOSE TO HIM. NO HARM TO PATIENT. NO SURGICAL DELAYS. DATE OF IMPLANT WAS ON (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 20439238 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR: SEPTIC SHOCK DEVICE AND PROCEDURE (RELATEDNESS): NO INFORMATION PROVIDED DATE OF EVENT: 04-NOV-2021, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT KNEE. TREATMENT/IMPACT: REQUIRES INPATIENT HOSPITALIZATION/RESOLVED WITH RESIDUAL EFFECTS.

  Patient problems: Septic Shock

  MAUDE report 20124739 ↗
• InjuryJul 26, 2024Fracture; Fracture

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO FEMORAL IMPLANT LOOSENING. THE NON-ARTICULAR SURFACE OF THE PRESS FIT (CEMENTLESS) CC FEMORAL COMPONENT SHOWS NO RELATIVE MOTION, SPARSE BONE WITH EXCELLENT INTERDIGITATION. AT REVISION THE TIBIAL INSERT HAD CRACKING AROUND THE RIM.

  Patient problems: Insufficient Information

  MAUDE report 19837146 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS COMPLAINING OF AN UNSTABLE KNEE, SO WE CHANGED THE POLY INSERT FOR A THICKER ONE. DOI: (B)(6) 2019 DOE: (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 19406404 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS DOWNSIZED FROM A 5X6MM TO A 5X5MM. NO HARM TO PATIENT AND NO DELAYS. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE : UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19380945 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO RULE OUT INFECTION. DOI: (B)(6) 2024. DOR:(B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19222476 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO SURGICAL DELAY. THE LOT NUMBER OF THE ORIGINAL FEMORAL COMPONENT WAS D23040563. ALSO, DEPUY CEMENT WAS USED IN THE ORIGINAL SURGERY HOWEVER, THE LOT NUMBER IS UNAVAILABLE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 18803028 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Loss of Range of Motion

  MAUDE report 18789912 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY WAS SWAPPED AND INCREASED TO 1MM IN THICKNESS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18587757 ↗