ATTUNE 1516-20-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295045809), received between Mar 6, 2019 and Sep 23, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that incision & Drainage.Affected side: Right side.

  Patient problems: Insufficient Information

  MAUDE report 50866793 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENT WITH ARTHROFIBROSIS WHICH REQUIRED POLY EXCHANGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 22133587 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS DISCOMFORT WITH KNEE. SURGEON DID REVISION TO REPLACE AND DOWNSIZE INSERT.

  Patient problems: Discomfort

  MAUDE report 21666041 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS EXPLANTED DUE TO EXPECTED INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 18476200 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF REVISION: (B)(6) 2023, DATE OF EVENT: (B)(6) 2022, (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 16843946 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S SURGICAL PROCEDURE WAS AN EXTENSOR MECHANISM RECONSTRUCTION. THE PATIENT HAD FALLEN AND BADLY INJURED HER PATELLA TENDON. DURING THE PROCEDURE, HER NATIVE PATELLA TENDON WAS EXCISED AND REPLACED BY A CADAVER ALLOGRAFT TENDON. DURING THE PROCEDURE, SURGEON ALSO EXCHANGED THE ATTUNE CR FB INSERT, FROM HER PRIMARY KNEE ARTHROPLASTY PROCEDURE IN 2017, WITH A FRESHER VERSION OF THE SAME SIZE INSERT. HER PATELLA IMPLANT, FROM HER PRIMARY KNEE ARTHROPLASTY PROCEDURE, WAS DISCARDED WHEN HER EXCISED NATIVE PATELLA TENDON WAS DISCARDED. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 15589006 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO SURGEON'S CLINIC FOR FOLLOW UP FROM HER PREVIOUSLY REVISED TIBIAL COMPONENT WITH ANTERIOR KNEE/TIBIAL PAIN. AFTER EXAMINATION, SURGEON RECOMMENDED SHORTENING THE TIBIAL STEM COMPONENT BECAUSE HE THOUGHT THE CURRENT IMPLANT WAS CAUSING HER PAIN. AFTER SEVERAL WEEKS OF CONSIDERATION, SHE DECIDED TO PROCEED WITH THE SURGEON'S RECOMMENDATION TO SHORTEN THE TIBIAL CONSTRUCT. SHE WAS THEN BROUGHT TO THE OPERATING ROOM WHERE A STAT GRAM STAIN WAS PERFORMED TO RULE OUT INFECTION. THE TIBIAL CONSTRUCT WAS REMOVED USING THE SURGEON'S TOOLS OF CHOICE, PRESERVING THE NATIVE TIBIA. AN RP COMPONENT WITH A FULLY POROUS PROXIMAL SLEEVE WITH 5MM AUGMENTS WAS IMPLANTED ACCORDING TO THE SURGEON'S PREFERENCE. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN LEFT SIDE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12661562 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS HAD PAIN SINCE HIS INITIAL SURGERY. SURGEON NOTED LAXITY. A POLY EXCHANGE WAS PERFORMED UNEVENTFULLY. DOI: APR. 30, 2021 DOR: SEP. 30, 2021 RIGHT KNEE

  Patient problems: Joint Laxity; Pain

  MAUDE report 12615628 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CHIEF COMPLAINT WAS PAIN AND LACK OF FLEXION. THE SURGEON WENT IN AND FOUND THE COMPONENTS TO BE WELL FIXED AND POSITIONED. HE REMOVED THE INSERT AND SOME SCAR TISSUE. HE THEN PROCEEDED TO REMOVE SOME HETEROTOPIC OSSIFICATIONS. SURGEON THEN TRIALED AN INSERT AND FOUND THE SAME THICKNESS INSERT THAT HE HAD REMOVED TO BE THE BEST FIT. THE FEMORAL, TIBIAL, AND PATELLA COMPONENTS WERE RETAINED. ONLY A NEW INSERT WAS REQUIRED. THANK YOU. DOI: (B)(6) 2012; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Loss of Range of Motion; No Code Available; Pain; Scar Tissue

  MAUDE report 8833629 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I& D INSERT EXCHANGE WAS PERFORMED. REVISED FOR INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8815729 ↗
• InjuryMar 6, 2019Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS DONE USING A KINEMATIC APPROACH.

  Patient problems: No Code Available

  MAUDE report 8395936 ↗