ATTUNE 1516-50-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10603295052425), received between Oct 19, 2017 and Jul 27, 2026 — classified as 140 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient was revised due to infection of knee. Surgeon did a poly swap.DOI: UnknownDOR: (b)(6) 2026Affected Side: Left Knee

  Patient problems: Unspecified Infection

  MAUDE report 50024487 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL KNEE THAT WAS INFECTED. THE SURGEON DID A WASHOUT WITH POLY EXCHANGE. ALL COMPONENTS ARE WELL FIXED. DOI: (B)(6) 2020 DOR: (B)(6) 2026 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25334786 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT TOTAL KNEE WAS UNSTABLE. IT WAS REVISED FROM 5 MM TO 7 MM INSERT. NO ADDITIONAL INFORMATION WAS AVAILABLE. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25160054 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO SURGEON IN CLINIC WITH KNEE STIFFNESS AND WAS UNABLE TO GET KNEE INTO FULL EXTENSION. SURGEON PERFORMED FULL REVISION OF PRIMARY ATTUNE IMPLANTS TO ATTUNE REVISION WITH SLEEVES ON BOTH SIDES (TIBIA AND FEMUR).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 22965777 ↗
• InjuryAug 26, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT HAD A COMPLEX PRIMARY TOTAL KNEE REPLACEMENT ON (B)(6) 2025 USING A PRIMARY ATTUNE PS FEMUR, ATTUNE PS ROTATING PLATFORM INSERT, ATTUNE REVISION ROTATING PLATFORM TIBIAL TRAY WITH ATTUNE REVISION TIBIAL SLEEVE AND ATTUNE REVISION PRESSFIT STEM. THE PATIENT HAD A PREVIOUS TIBIAL PLATEAU FRACTURE THAT HAD BEEN REPAIRED USING PLATES AND SCREWS, WHICH HAD SUBSEQUENTLY BEEN REMOVED PRIOR TO THE TOTAL KNEE REPLACEMENT SURGERY. AT THE TIME OF THE TKR SURGERY, NO CONCERNS WERE NOTED. POST-SURGERY, THE PATIENT¿S MEDIAL COLLATERAL LIGAMENT APPEARS TO HAVE FAILED (THIS OCCURRED 2 DAYS POST-OP ON (B)(6) 2025), RESULTING IN THE KNEE BEING IN SEVERE VALGUS AND X-RAY INDICATING THAT THE POLY INSERT WAS NOW ROTATED OUT OF ITS INITIAL POSITION. THE KNEE WAS SUBSEQUENTLY PLACED IN A RANGE OF MOTION BRACE AND FOLLOW-UP X-RAYS SHOWED THE KNEE TO BE IN GOOD ALIGNMENT IN BOTH THE AP AND LATERAL VIEWS. AT THIS STAGE, NO FURTHER ACTION IS PLANNED BUT THE PATIENT WILL BE REVIEWED IN A COUPLE OF WEEKS.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 22895395 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO ARTHROFIBROSIS AND PAIN

  Patient problems: Adhesion(s); Pain

  MAUDE report 21978629 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S MEDIAL TIBIAL BONE WAS COLLAPSING SO THE EXISTING TIBIAL BASE AND POLY WERE REMOVED AND THEN REVISED PATIENT WITH NEW IMPLANTS. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED ORE SUCCESSFULLY COMPLETED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21776901 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ATTUNE RIGHT IMPLANTED ON (B)(6) 2024 IS HAVING INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 21448163 ↗
• InjuryFeb 12, 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21364272 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. THE IMPLANTS WERE REMOVED USING OSTEOTOMES AND MILD IMPACTION FORCE. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2017, DOR: (B)(6)2025, AFFECTED SIDE: LEFT KNEE."

  Patient problems: Pain

  MAUDE report 21173729 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE REPLACEMENT. PATIENT FELL IN THERAPY AND OPENED THE INCISION AND TORE THE PATELLA TENDON. SURGEON WASHED OUT THE WOUND AND EXCHANGED POLYETHYLENE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 21105406 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NONE TO MY KNOWLEDGE, ACUTE SURGICAL ACCESS IS DETERMINED BY THE ORTHOPEDIC TEAMS.

  Patient problems: Unspecified Infection

  MAUDE report 20762906 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S POLY WAS UPSIZED. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20622963 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD A REVISION OF LEFT SIDE DUE TO FALL AND WOUND DEHISCENCE. WASHED IT OUT AND CHANGED THE INSERT. NO SURGICAL DELAY OR PATIENT CONSEQUENCES. ORIGINAL DATE OF IMPLANT WAS (B)(6) 2024.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 20612617 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENTS RECEIVED FOR KNEE STIFFNESS, DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: DEFINITELY, PROCEDURE RELATED: DEFINITELY, DATE OF EVENT: 16 SEP 2024, DATE OF IMPLANT: ON (B)(6) 2023, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: PHYSICAL THERAPY, DEPUY SYNTHES PRODUCT USED: COMPONENT TYPE: FEMORAL COMPONENT, CATALOG NUMBER: 150410105, LOT NUMBER ID: 3851774, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL BASE COMPONENT, CATALOG NUMBER: 150680006, LOT NUMBER ID: 4022166, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL STEM, CATALOG NUMBER: 151310110, LOT NUMBER ID: J8383W, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL SLEEVE, CATALOG NUMBER: 151111201, LOT NUMBER ID: J94Z36, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL INSERT COMPONENT, CATALOG NUMBER: 151650505, LOT NUMBER ID: 3787761, UDI: (B)(4). COMPONENT TYPE: CEMENT, CATALOG NUMBER: 3003940002, LOT NUMBER ID: AX42AK0B03, DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Muscular Rigidity

  MAUDE report 20407270 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO:(B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR KNEE STIFFNESS DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: DEFINITELY PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 16 SEP 2024 DATE OF IMPLANT: (B)(6) 2023 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT TREATMENT/IMPACT: PHYSICAL THERAPY DEPUY SYNTHES PRODUCT USED: COMPONENT TYPE: FEMORAL COMPONENT CATALOG NUMBER: 150410105 LOT NUMBER ID: 3851774 DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL BASE COMPONENT CATALOG NUMBER: 150680006 LOT NUMBER ID: 4022166 DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL STEM CATALOG NUMBER: 151310110 LOT NUMBER ID: J8383W DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL SLEEVE CATALOG NUMBER: 151111201 LOT NUMBER ID: J94Z36 DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL INSERT COMPONENT CATALOG NUMBER: 151650505 LOT NUMBER ID: 3787761 UDI:(B)(4). COMPONENT TYPE: CEMENT CATALOG NUMBER: 3003940002 LOT NUMBER ID: AX42AK0B03 DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Muscular Rigidity

  MAUDE report 20407149 ↗
• InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2024, ON THE RIGHT KNEE DUE TO INFECTION. ORIGINAL IMPLANT DATE UNKNOWN. IT IS NOT KNOWN WHEN THE INFECTION STARTED. UNKNOWN SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20261334 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN. DOCTOR DECIDED TO DO A REVISION OF PRIMARY TKA. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19950441 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTION. DOI: (B)(6), 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19723848 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS ACCUSING PAIN.

  Patient problems: Pain

  MAUDE report 19587480 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE I & D WITH POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2023. DOR: (B)(6) 2024 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19528301 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE. POLY EXCHANGE WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19483643 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATTUNE ROTATING PLATFORM POSTERIOR STABILIZED CEMENTED CONSTRUCT IN (B)(6) 2022. INITIALLY THE KNEE DID VERY WELL BUT RECENTLY PATIENT FELT SOME INSTABILITY WHILE WALKING. IT WAS NOTED THAT A 7MM POLY CREATED MORE STABILITY. THE 5 MM POLY WAS SWAPPED OUT FOR A SLIGHTLY THICKER INSERT. NO INFECTION WAS SUSPECTED OR NOTED. ALL IMPLANTS WERE WELL FIXED AND THERE WAS NO CONCERN OF LOOSENING. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19360322 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO KNEE INFECTION, SURGEON EXPLANTED COMPONENTS AND REVISING WITH TEMPORARY SPACER. THERE WAS NO LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19312737 ↗
• InjuryMar 20, 2024Adverse 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: Pain; Unspecified Tissue Injury

  MAUDE report 18947237 ↗