ATTUNE 1516-30-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295047902), received between Mar 2, 2018 and Jan 16, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Unintended Movement” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI- (B)(6) 2025, DOR- (B)(6) 2026, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24102985 ↗
• InjuryDec 30, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF ATTUNE CR RP IMPLANT AFTER SPIN-OUT OF INLAY IMPLEMENTED WITH VRAS. CONVERSION FROM RP TIBIA TO ATTUNE REVISION TIBIA FB WITH STEM AND AUGMENT.

  Patient problems: Insufficient Information

  MAUDE report 23922676 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED EXCISES EXCESS SCAR TISSUE WITH POLY EXCHANGE. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Adhesion(s)

  MAUDE report 22440266 ↗
• InjurySep 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. TIBIA INSERT WAS REMOVED AND REPLACED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15397625 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF KNEE INSTABILITY. SURGEON EXAMINED THE KNEE AND DETERMINED THE LIGAMENTS HAD STRETCHED AND PATIENT WOULD BENEFIT FROM A POLY EXCHANGE. THE SIZE 6, 10MM CR INSERT WAS REMOVED AND REPLACED WITH SIZE 6, 16MM POLY. THE KNEE WAS RUN THROUGH A FULL RANGE AND STABILITY WAS CONFIRMED. DOI: (B)(6) 2020. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14138703 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN BONE CEMENT WAS USED. THE ANATOMIC PATELLA COMPONENT WAS RETAINED DURING REVISION. THE THAT ORIGINAL SURGERY PERFORMED BY DR (B)(6). DOI : (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13720299 ↗
• InjuryOct 20, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE REVISION WAS DONE DUE TO ANOTHER EPISODE OF BEARING SPIN OUT. THIS COMPLAINT IS RELATED TO (B)(4). DOI: (B)(6) 2021. DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12664164 ↗
• InjuryOct 13, 2021Unintended Movement; Unintended Movement

  1. PLEASE CLARIFY IF THERE WAS SURGICAL DELAY. NO DELAY REPORTED.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 12626888 ↗
• InjuryOct 12, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED AS "SURGEON UPSIZED POLY INSERT DUE TO UNSTABLE KNEE. HE INCREASED FROM 10MM TO 14MM CR RP INSERT. SURGEON WAS HAPPY WITH STABILITY AFTER REPLACING POLY. NO DEFICIENCIES WERE NOTED WITH THE PRODUCT AND NO DELAY IN THE PROCEDURE. POLY WAS DAMAGED AND DISPOSED OF BY HOSPITAL. IT WILL NOT BE RETURNED." DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12617418 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. REVISED FEMUR TO A CRS IMPLANT. DOI: (B)(6) 2014 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11977526 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11871310 ↗
• InjuryFeb 12, 2021Unintended Movement; Unintended Movement

  MOBILE BEARING SPUN OUT. REVISED FEMUR TO CRS W/PS INSERT.

  Patient problems: Insufficient Information

  MAUDE report 11322013 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE TIBIAL IMPLANT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10750875 ↗
• InjuryOct 22, 2020Unintended Movement; Unintended Movement

  REVISION OF PRIMARY ATTUNE KNEE CR RP COMPONENTS, WITH PRIMARY CAUSE BEING BEARING SPIN OUT. PRIMARY OPERATION WAS ON (B)(6) 2020. PUT IN A 6N LEFT CR FEMUR, SIZE 5 RP BASE PLATE, SIZE 6, 7MM CR RP INSERT AND 32 ANATOMIC PATELLA. PATIENT PRESENTED ON (B)(6) 2020 WITH BEARING SPINOUT, AND HAD A BEARING EXCHANGE TO 10MM INSERT. IT WAS FOUND HERE THAT PCL HAD BEEN RUPTURED POST THE INDEX PROCEDURE. PATIENT WAS PUT INTO A ROM BRACE, BUT DESPITE THAT SUFFERED ANOTHER SPIN OUT WITHIN 2 WEEKS. SO TODAY THEY WERE REVISED WITH REMOVAL OF ALL COMPONENTS, AND REPLACED WITH SZ 4 ATTUNE REVISION RP TIBIA WITH 37 SLEEVE AND 60MM STEM, SIZE 6 REVISION FEMUR WITH POSTERIOR AUGMENTS AND 110 STEM, AND A 6, 16MM REVISION INSERT. IN BALANCING THE KNEE IT WAS APPARENT THAT THE PATIENT'S FLEXION GAP WAS SIGNIFICANTLY LOOSER THAN EXTENSION, SO THE SURGEON SACRIFICED SOME JOINT LINE IN ORDER TO BALANCE EXTENSION TO FLEXION. THE LCL REQUIRED SOME REPAIR, AND THE SURGEON WONDERS WHETHER THIS IS ONE POTENTIAL CAUSE OF SUCH SIGNIFICANT INSTABILITY. DOI: (B)(6) 2020 DOR: (B)(6) 2020 (INSERT EXCHANGE) DOR: (B)(6) 2020 (TOTAL REVISION) LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10719450 ↗
• InjurySep 15, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  RECENT TOTAL KNEE REPLACEMENT, REQUIRED THE POLYETHYLENE INSERT TO BE UPSIZED DUE TO INSTABILITY.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10536574 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9701181 ↗
• InjuryDec 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION RIGHT SIDE - ATTUNE RP TO SROM. REPORTED REVISION OF THE RIGHT SIDE AS PATIENT CONTINUED TO DISLOCATE FOLLOWING MAJOR FALL AND INCREASED POLY WIDTHS. DISLOCATION - RESULTING IN REVISION SURGERY FOR HINGE TKR.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9426528 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO PS KNEE DUE TO INSTABILITY AND PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8210862 ↗
• InjuryMar 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. DOI: (B)(6) 2016. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 7309273 ↗