ATTUNE 1516-50-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295052296), received between Oct 12, 2017 and Jan 29, 2026 — classified as 42 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE A KNEE INSERT EXCHANGE REVISION PROCEDURE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24215846 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ANTERIOR KNEE PAIN. WENT BACK AND RESURFACED THE PREVIOUSLY UNRESURFACED PATELLA. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24116270 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD FLEXION INSTABILITY. INSERT WAS UPSIZED BY 2MM. THERE WAS NO DELAY OR PATIENT INJURY. LOT IS UNKNOWN. NO OTHER INFORMATION IS KNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23391327 ↗
• InjurySep 11, 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. UPSIZED POLY. DOI: UNKNOWN DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23033594 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT POLY SWAP DUE TO FLEXION CONTRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 21700323 ↗
• InjuryNov 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE LINER IS DAMAGED OR CRACKED, REPLACE THE ATTUNE-RP-LINER. A NEW ONE WAS USED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 20696004 ↗
• InjuryOct 28, 2024Adverse 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 HYPEREXTENDED KNEE. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20543981 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNSTABLE KNEE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI- (B)(6) 2022. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20493260 ↗
• InjurySep 19, 2024Adverse 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 20258393 ↗
• InjuryFeb 27, 2024Adverse 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 GLOBAL INSTABILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18789059 ↗
• InjuryFeb 21, 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: Joint Laxity

  MAUDE report 18747431 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MID FLEXION INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18747381 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WERE NO SURGICAL DELAYS OR ALLEGATIONS AGAINST THE ATTUNE SHIM SZ3 8MM. THERE WAS ALSO NO INSTABILITY RELATED TO POLYETHYLENE WEAR AND NO REPORTED MALPOSITION OF COMPONENTS THAT LED TO INSTABILITY. IT ALSO STATES THAT THERE WERE NO UNDERSIZED COMPONENTS ON THE PRIMARY SURGERY AND PRIMARY RESECTIONS WERE NOT EXCESSIVE AND TO NORMAL LIMITS.

  Patient problems: Joint Laxity

  MAUDE report 18359949 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED BECAUSE OF CONSTANT KNEE PAIN. THERE WAS NO EVIDENCE OF LOOSENING OR INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17731499 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED PATELLA AND INSERT, DID A WASHOUT AND PUT IN NEW IMPLANTS. UNKNOWN SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 16876138 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT TKA. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16417248 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND THE SURGEON FELT THAT THE RP INSERT CONTRIBUTING TO SYNOVITIS. THE IMPLANTS WERE WELL FIXED AND WELL ALIGNED. REMOVED THE TRAY AND PLACED A FIXED BEARING TIBIA AND INSERT. CHANGED THE PATELLA AFTER CUT TO THIN- TRACKING LATERALLY. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15649795 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D WITH REMOVAL OF IMPLANTS WAS PERFORMED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15587814 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15520424 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14373001 ↗
• InjuryMay 10, 2022Adverse 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 ATTUNE KNEE WITH A GAP MISBALANCE. THE KNEE WAS TOO TIGHT IN FLEXION WITH NORMAL EXTENSION. THE SURGEON DECIDED THAT THE ONLY WAY TO SOLVE THE BALANCE ISSUE WAS TO REMOVE THE FEMUR AND THE TIBIAL TRAY. THESE COMPONENTS WERE WELL FIXED. THE PATELLA WAS WELL FIXED AND RETAINED. THE SURGEON WAS ABLE TO GET THE KNEE TO BALANCE BETTER WITH NEW COMPONENTS. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Laxity; Muscular Rigidity

  MAUDE report 14346103 ↗
• MalfunctionApr 27, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE IMPLANT ARRIVED WITH THE CELLOPHANE, BUT WHEN WE OPENED THE BOX WE NOTICED THAT THE LABELS DID NOT MATCH THE BOX. FOR THIS REASON, THE IMPLANT WAS NOT OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218894 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS UNSTABLE KNEE. INCREASED POLY THICKNESS. NO FURTHER INFORMATION IS AVAILABLE. DOI- (B)(6) 2021; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14167264 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 13633811 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTIONS: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? D. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? ANSWERS: A. NO. NOT RELATED TO POLY WEAR. B. NO. IMPLANTS WERE WELL POSITIONED C. YES. IT WOULD APPEAR THAT THE POLY INSER WAS UNDERSIZED. ALL OTHER COMPONENTS WERE SIZED CORRECTLY D. NO. THE INSTABILITY WAS ¿GLOBAL¿. IN OTHER WORDS, IT WAS LOOSE THROUGHOUT THE RANGE OF MOTION.

  Patient problems: Joint Laxity

  MAUDE report 13262040 ↗