ATTUNE 1516-30-712Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295048039), received between Oct 10, 2017 and Nov 19, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 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 PAIN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 23597104 ↗
• InjurySep 11, 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 PAIN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 23026772 ↗
• InjuryMay 29, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CLICKING. THERE WAS NO LOOSENING OF IMPLANTS, SLIGHT BONE GROWTH WAS CLEARED FROM NOTCH AND DECREMENT WAS PERFORMED. PATIENT REPORTED NO PAIN OR DECREASE IN MOTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification

  MAUDE report 22104521 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR POLY SWAP DUE TO STABILITY. POLY UPSIZED. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16105834 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, SO COMPONENTS WERE EXPLANTED AND KNEE CEMENT SPACER IMPLANTED. IMPLANTS ARE NOT AVAILABLE FOR RETURN. LOT NUMBERS WERE NOT VISIBLE ON POLY AND FEMUR. NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11716720 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. THERE ARE NO IMPLANT RECORD AVAILABLE, JUST AN OPERATIVE NOTE. CEMENT MANUFACTURER UNKNOWN. DOI: (B)(6) 2013; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Adhesion(s); Cyst(s); Muscular Rigidity; No Code Available

  MAUDE report 10240939 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE STIFFNESS : ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT KNEE). TREATMENT: MANIPULATION OF RIGHT KNEE UNDER ANESTHESIA.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9921197 ↗
• InjuryOct 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6937591 ↗