ATTUNE 1516-50-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295052173), received between Aug 10, 2017 and Jun 18, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 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 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY SWAP DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22286375 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 21414795 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION. IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANT SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21199720 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND POOR MOTION. UPON EXAM MILD INSTABILITY IS NOTED BUT HAS LIMITED MOTION, 10-85. INTRAOPERATIVELY, A POSTERIOR RELEASE IS PERFORMED AND FOUND TO BE RELATIVELY STABLE IN BOTH FLEXION AND EXTENSION AND FULL EXTENSION IS ACHIEVED ONCE THE POSTERIOR RELEASE WAS PERFORMED. MILD INSTABILITY IS NOTED AT ROUGHLY 20 DEGREES OF FLEXION, A THICKER INSET IS PLACED AND FOUND TO NOT LOOSE SIGNIFICANT MOTION AND INSTABILITY AT 20 DEGREES OF FLEXION IS REDUCED. NO DELAY OR PATIENT HARM OCCURS. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 19173705 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF PAIN. THE FEMORAL COMPONENT AND TIBIAL COMPONENT WERE NOT LOOSE. THE SURGEON DEBRIDED THE KNEE AND UPSIZED TO A 10MM POLY. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2019. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16271605 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR GLOBAL INSTABILITY OF PRIOR TKA. DOI: (B)(6) 2016; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12196492 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. SURGEON THOUGHT IT WAS FROM A LOOSE TIBIA. UPON REMOVAL OF THE TIBIA IT APPEARED TO BE WELL FIXED. SURGEON JUST REVISED THE TIBIAL SIDE TO AN ATTUNE REVISION RP BASEPLATE WITH A SLEEVE AND STEM. DOI: UNKNOWN. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12196281 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A PRIMARY RIGHT ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON NOTED THE PROCEDURE WAS COMPLEX DUE TO THE PATIENT¿S OBESITY. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN, STIFFNESS, AND ARTHROFIBROSIS. UPON ENTERING THE JOINT, ABUNDANT SCAR TISSUE WAS DEBRIDED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT WAS REVISED WITH A DEPUY TC3/MBT REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Pain

  MAUDE report 11726843 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: ORAL MEDICATION.

  Patient problems: No Code Available; Pain

  MAUDE report 10575352 ↗
• InjuryAug 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6784040 ↗