ATTUNE 1516-50-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10603295052579), received between Jul 13, 2017 and May 1, 2026 — classified as 113 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 25 most recent of 114 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INCISION AND DRAINAGE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 25060091 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INSTABILITY. WENT UP A POLY SIZE. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24966302 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASH OUT AND POLY EXCHANGE WAS PERFORMED FOR INFECTION. ORIGINAL SURGERY WAS DONE IN (B)(6) OF 2025. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24800697 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SOFT TISSUE INFLAMMATION. THERE WAS LOOSENING OF FEMUR AND TIBIA AT BONE TO CEMENT INTERFACE. COMPONENTS REMOVED AND REVISION COMPONENTS REPLACED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24036438 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY, SURGEON UP SIZED POLY. DOI-UNKNOWN. DOR-(B)(6) 2025. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23922760 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EXCESSIVE LAXITY IN EXTENSION AND DEFICIT IN FLEXION ON A TKA WITH ATTUNE FROM 2022. PATIENT EXPERIENCED REDUCED MOBILITY AND PAIN, AND REQUIRED REVISION SURGERY.

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

  MAUDE report 23413379 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL KNEE DONE BY THE DOCTOR ON (B)(6) 2018. THE PATIENT DEVELOPED SOME INSTABILITY IN THE KNEE AND WAS BROUGHT IN FOR REVISION. SIZE 6X6 RPPS INSERT WAS REMOVED AND A NEW SIZE 6X10MM RPPS INSERT WAS IMPLANTED. NO DELAY IN SURGERY. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23368061 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A TOTAL KNEE IN 2022. CUSTOMER WAS NOT ABLE TO FIND THE EXACT DATE IN 2022 ON WHICH THE SURGERY WAS PERFORMED. PATIENT PRESENTED WITH INFECTED TOTAL KNEE. SURGEON REMOVED THE TOTAL KNEE AND REPLACED WITH ANTIBIOTIC IMPREGNATED SURE-SPACE CEMENT SPACER. PATELLA WAS LEFT IN PLACE. ALL AVAILABLE INFORMATION HAS BEEN FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22924118 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO UPSIZE POLY TO ADDRESS KNEE INSTABILITY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22532153 ↗
• InjuryJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND DISLOCATED THE TIBIAL INSERT. SURGEON REPLACED TIBIAL INSERT. THERE WERE NO BROKEN PIECES AND NO DELAYS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22370510 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON IS REVISING DUE TO KNEE PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22321686 ↗
• InjuryMay 22, 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 HETEROTOPIC BONE FORMATION IN THE SUPRAPATELLAR POUCH AND POSTERIOR KNEE JOINT. POLY WAS REMOVED TO GAIN ACCESS TO THE POSTERIOR KNEE SPACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Extraskeletal ossification

  MAUDE report 22068711 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FROM PRIMARY ATTUNE TO ATTUNE REVISION. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED AREA: RIGHT KNEE.

  Patient problems: Discomfort

  MAUDE report 22004282 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO KNEE INSTABILITY. THE SURGEON SWAPPED OUT CURRENT INSERT FOR A THICKER ONE. THERE WERE NO DELAYS, AND NO INJURIES. DOI: (B)(6)2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21987784 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND REOPENED INCISION/CAPSULE. SURGEON PERFORMED A WASH OUT AND POLY EXCHANGE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2025 , DOR: (B)(6) 2025 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 21963718 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 PATIENT HAD UNDERWENT RIGHT KNEE WITH VELYS. ON (B)(6) 2025, PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO PAIN, SWELLING, AND INSTABILITY. PATIENT WAS FOUND TO HAVE ASEPTIC FEMORAL AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS UNDERLYING FIBROUS TISSUE AND THE CEMENT WAS REMOVED AFTER THE TIBIAL COMPONENT AND FEMORAL COMPONENTS WERE REMOVED. THE PATELLA WAS NOTED TO HAVE BEEN REMOVED AS WELL, BUT THERE WAS NO MENTION IMPLANT LOOSENING RELATED TO THE PATELLA. COMPETITOR IMPLANTS WERE PLACED AT REVISION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fibrosis; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21901366 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH ATTUNE PRODUCTS. AFTER THE SURGERY, INFECTION OCCURRED. A REVISION SURGERY WAS PERFORMED, AND THE INSERT IN QUESTION WAS REPLACED WITH A NEW ONE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21687205 ↗
• InjuryMar 5, 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 INSTABILITY. A POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21528947 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SCRAPE HIS INCISION. THE WOUND WAS OPENED. POLY SWAP AND DEBRIDEMENT. NO ISSUES OR BROKEN PIECES. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 21444776 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO AN INFECTION. ALL PARTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. DATE OF THE ORIGINAL PRIMARY SURGERY WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21439050 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO.

  Patient problems: Joint Laxity

  MAUDE report 21373939 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH AN INFECTION IN KNEE POST UTI AND EXTENDED HOSPITALIZATION DUE TO THIS. IT HAS BEEN ROUGHLY ONE MONTH SINCE THE UTI. SURGEON CHOSE TO PERFORM A ONE STAGE, DUAL SET UP KNEE REVISION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS DUE TO THE DURATION OF INFECTION WHICH HAD APPEARED TO SEED KNEE REPLACEMENT. NO DELAYS OR PATIENT HARM WERE NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21311757 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD RIGHT KNEE REPLACEMENT SURGERY. PATIENT'S KNEE DID NOT GET FULL EXTENSION AND DEVELOPED SCAR TISSUE. A POLYETHYLENE EXCHANGE WITH A THINNER POLY AND EXCISION OF SCAR TISSUE WAS PERFORMED WITHOUT ISSUE. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 21294005 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH LINER EXCHANGE AND WASHOUT DUE TO INFECTED TOTAL KNEE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21047608 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. ATTUNE KNEE IMPLANTS WERE IMPLANTED AND VELYS WAS USED. ON (B)(6) 2024, THE PATIENT HAD REVISION RIGHT TOTAL ARTHROPLASTY TO ADDRESS MECHANICAL ASEPTIC LOOSENING OF RIGHT TOTAL KNEE ARTHROPLASTY. IT WAS REPORTED THAT PATIENT HAD RECURRENT EPISODES OF ACHING PAIN, INSTABILITY, AND SWELLING. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE EASILY REMOVED AND THERE WAS NOTED FIBROUS TISSUE UNDERLYING THE COMPONENTS. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20845706 ↗