ATTUNE 1518-20-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295541738), received between Oct 3, 2023 and Jun 19, 2026 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND TWISTED HER KNEE. END RESULT WAS A TEAR OF THE MEDIAL RETINACULUM. SURGEON SWAPPED THE POLY AND REPAIRED THE RETINACULUM. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 25562741 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD PERFORMED A LEFT KNEE REPLACEMENT ON (B)(6) 2024. THE PATIENT'S PATELLA HAD NOT BEEN RESURFACED DURING THE FIRST SURGERY. THE PATIENT HAD BEEN COMPLAINING OF ANTERIOR KNEE PAIN, SO SURGEON HAD DECIDED TO REVISE THE KNEE BY PLACING A PATELLA AND HAD ALSO PERFORMED A POLY SWAP DURING THE PROCEDURE. DOI-(B)(6) 2024. DOR-(B)(6) 2026. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24791231 ↗
• MalfunctionDec 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) WITH A CRUCIATE-RETAINING FEMORAL MULTI-SIZE POLYETHYLENE, THE SURGEON IMPACTED THE POLYETHYLENE INSERT AND FELT THE LOCKING MECHANISM DID NOT ENGAGE CORRECTLY. THE SURGEON REMOVED AND REINSERTED THE INSERT SEVERAL TIMES AND OPENED A SECOND AND THEN A THIRD POLYETHYLENE WITH THE SAME ISSUE. AFTER A FOURTH POLYETHYLENE WAS OPENED AND STILL DID NOT SATISFY THE SURGEON, A STEMMED TIBIAL COMPONENT WAS OPENED IN CASE TRAY REMOVAL WAS REQUIRED AND TO EVALUATE WHETHER THE TIBIAL TRAY MIGHT BE CAUSING THE LOCKING FAILURE; THE TEAM ATTEMPTED TO ENGAGE THE POLYETHYLENE AND TRAY ON THE BACK TABLE. THE SURGEON WAS NOT CONVINCED THAT CHANGING TRAYS WOULD RESOLVE THE PROBLEM AND ULTIMATELY IMPLANTED A 6X7 LEFT MULTI-SIZE POLYETHYLENE, ALTHOUGH THE SURGEON REMAINED NOT FULLY SATISFIED AT THE CONCLUSION OF THE CASE. NO FURTHER INFORMATION IS AVAILABLE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830304 ↗
• MalfunctionDec 17, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) WITH A CRUCIATE-RETAINING FEMORAL MULTI-SIZE POLYETHYLENE, THE SURGEON IMPACTED THE POLYETHYLENE INSERT AND FELT THE LOCKING MECHANISM DID NOT ENGAGE CORRECTLY. THE SURGEON REMOVED AND REINSERTED THE INSERT SEVERAL TIMES AND OPENED A SECOND AND THEN A THIRD POLYETHYLENE WITH THE SAME ISSUE. AFTER A FOURTH POLYETHYLENE WAS OPENED AND STILL DID NOT SATISFY THE SURGEON, A STEMMED TIBIAL COMPONENT WAS OPENED IN CASE TRAY REMOVAL WAS REQUIRED AND TO EVALUATE WHETHER THE TIBIAL TRAY MIGHT BE CAUSING THE LOCKING FAILURE; THE TEAM ATTEMPTED TO ENGAGE THE POLYETHYLENE AND TRAY ON THE BACK TABLE. THE SURGEON WAS NOT CONVINCED THAT CHANGING TRAYS WOULD RESOLVE THE PROBLEM AND ULTIMATELY IMPLANTED A 6X7 LEFT MULTI-SIZE POLYETHYLENE, ALTHOUGH THE SURGEON REMAINED NOT FULLY SATISFIED AT THE CONCLUSION OF THE CASE. NO FURTHER INFORMATION IS AVAILABLE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830210 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23821670 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY EXCHANGE DUE TO INFECTION. PATELLA WAS LOOSE. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23569498 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REVISED THAT PATIENT HAD KNEE INSTABILITY. POLY WAS EXCHANGED AND UPSIZED 6MM LARGER. NO PATIENT INJURY OR DELAY. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23521978 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO LAXITY IN THE KNEE. UPSIZED THE POLY.

  Patient problems: Joint Laxity

  MAUDE report 23488323 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO LAXITY IN THE KNEE. SURGEON UPSIZED THE POLY TO A 16MM. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22840775 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22665397 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE PAIN. THE INSERT WAS SWAPPED UP 1MM AND PATELLA WAS RESURFACED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22367155 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOCTOR DECIDED TO CHANGE POLY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22212329 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN WITH A SUSPECTED INFECTION OF THE LEFT KNEE. THE TIBIAL INSERT WAS REMOVED AND JOINT WAS WASHED OUT. NEW TIBIAL INSERT WAS PUT IN. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2024. DOR:(B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22035239 ↗
• InjuryMay 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 INFECTION AND UNDERWENT POLY SWAP. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22003751 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TENDON REPAIR AND A POLY SWAP. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20835795 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LOTS OF LAXITY AND POLY WAS SWAPPED FOR A 16MM THICK INSERT. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20582076 ↗
• InjuryOct 31, 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? NO OTHER THEN STANDARD WASHOUT AND POLY EXCHANGE

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 20577234 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENCE CONSEQUENCE.

  Patient problems: Unspecified Infection

  MAUDE report 20419620 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF KNEE. SURGEON WASHED OUT AND POLY SWAP WAS PERFORMED ON (B)(6) 2024. ALL IMPLANTS WERE EXPLANTED AND A TEMPORARY SPACER WAS PUT IN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19514735 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2024. SURGEON PRESENTED IN CLINIC WITH SIGNS OF INFECTION. POLY WAS EXCHANGED, AGGRESSIVE DEBRIDEMENT WAS PERFORMED AND NEW POLY WAS PLACED. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19192564 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2023 DATE OF REVISION: (B)(6) 2023 (LEFT KNEE) TREATMENT: TIBIA WAS REVISED

  Patient problems: Joint Laxity

  MAUDE report 18669212 ↗
• InjuryJan 26, 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: Unspecified Infection

  MAUDE report 18586224 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS UPSIZED FROM A 6MM MEDIAL STABILIZED TO A 12MM MEDIAL STABILIZED POLY FOR UNKNOWN REASON. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17875581 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELT LIKE HER KNEE WAS LOOSE OR UNSTABLE SO THE SURGEON PUT A BIGGER IMPLANT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17859562 ↗