ATTUNE 1516-50-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10603295052449), received between Apr 12, 2018 and Jul 29, 2026 — classified as 77 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

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

  It was reported that the poly upsized for instability. There was no delays and no broken instrument. There was no harm to patient.Affected side: Left Knee.

  Patient problems: Joint Laxity

  MAUDE report 50068683 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINS OF LACKING EXTENSION AND FLEXION. PATIENT HAS A 15 DEGREE FLEXION CONTRACTURE AND FLEXES TO 90 DEGREES. UNDER ANESTHESIA, THE PATIENT COULD FLEX TO ABOUT 120 DEGREES. SURGEON EXCISED SCAR TISSUE AND DOWN SIZED POLY FROM A 7MM TO A 6MM. PATIENT ON THE TABLE HAD ALMOST STRAIGHT LEG AND FLEXION "HEEL TO BUTT" (145 DEGREEES?) DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

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

  MAUDE report 25457160 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT WAS REVISED TO A THICKER 10MM POLY FOR STABILITY AND THE PATELLA WAS RESURFACED. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25013159 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAPPED OUT FOR INSTABILITY AND WENT UP TO A 5X12MM POLY. NO HARM TO PATIENT. NO DELAYS. NO BROKEN INSTRUMENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23705027 ↗
• InjuryNov 20, 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. 7MM INSERT WAS EXCHANGED FOR A 12. ALL IMPLANTS WERE WELL FIXED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23610212 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOWNSIZED THE THICKNESS OF POLY.

  Patient problems: Insufficient Information

  MAUDE report 23546331 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: TIBIA SUBSIDED WHICH LED TO LIGAMENTAL INSTABILITY. IT CANNOT BE DETERMINED IF MALPOSITIONING/UNDERSIZING OF EITHER COMPONENT LED TO THIS.

  Patient problems: Joint Laxity

  MAUDE report 23351136 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. WASHED OUT THE KNEE AND PUT IN NEW INSERT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23346550 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INFECTED. POLY WAS SWAPPED ALONG WITH I&D/WASHOUT. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23289634 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RESECTION FOR INFECTION, I&D POLY EXCHANGE PERFORMED (B)(6) 2025. THE PATIENT CONTINUED TO HAVE WOUND PROBLEMS AND DRAINAGE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22843014 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD I&D AND POLY EXCHANGE FOR INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22518797 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? LIGAMENTOUS INSTABILITY? B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO REPORTED MALPOSITION. C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NONE REPORTED. D. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NONE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 22089261 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL OF FEMUR, TIBIA AND INSERT DUE TO PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21975449 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT WAS REVISED BECAUSE THEIR KNEE WAS STIFF AND THEY DID NOT HAVE A FULL RANGE OF MOTION. DOCTOR REMOVED THE SIZE 5 - 7MM BEARING, REMOVED SCAR TISSUE, AND THEN IMPLANTED A SIZE 5 - 5MM BEARING. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

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

  MAUDE report 21738352 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. DOI: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21223525 ↗
• InjuryJan 15, 2025Adverse 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: Unspecified Infection

  MAUDE report 21157629 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO THERE WAS NO DELAY.

  Patient problems: Joint Laxity

  MAUDE report 20586699 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS OSTEOLYTIC CHANGES IN THE PATELLA AND INCREASING PAIN & SWELLING IN PATIENT'S KNEE. TOTAL KNEE REVISION WAS PERFORMED. IT IS UNKNOWN IF THE PATIENT HAD A FALL OR OTHER TRAUMATIC EVENT. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. THERE WERE NO BROKEN IMPLANTS OR INSTRUMENTS. NO ADVERSE OCCURRENCES TO THE PATIENT. NO SURGICAL DELAY. LOT NUMBERS WERE READ FROM THE SURGICAL FIELD, NO OTHER RECORD IS AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20533520 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT NEEDED BIGGER SIZE IMPLANT. SURGICAL DELAY UNKNOWN. DOE: (B)(6) 2024 AFFECTED SIZE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19135566 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN. A POLY SWAP WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6)2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 18803886 ↗
• InjuryFeb 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019, DATE OF EVENT: (B)(6) 2024, (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA AND ARTHROSCOPY.

  Patient problems: Adhesion(s)

  MAUDE report 18637375 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D POLY SWAP FOR SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM IT. SURGICAL DELAY WAS UNKNOWN. DOI:(B)(6) 2023. DOR:(B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17868699 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A WASHOUT AND POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17833660 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SWAPPED INSERT DUE TO INSTABILITY, NOT RELATED TO MISPOSITIONING OF OTHER IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17603585 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17172160 ↗