ATTUNE 1516-40-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10603295050216), received between Jan 9, 2018 and Aug 13, 2026 — classified as 64 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 68 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50239367 ↗
• InjuryJun 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT SPONTANEOUS DECAPITATION OF POLYETHYLENE OF THE TIBIAL BASE CAUSING PAIN AND LIMITATIONS OF ARTICULAR AMPLITUDES. NECESSITY OF SURGICAL REVISION FOR POLYETHYLENE CHANGE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25461680 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINS OF ANTERIOR KNEE PAIN POST RTKA WHERE THE NATIVE PATELLA WAS NOT RESURFACED. COMPONENTS WERE WELL FIXED AND WELL ALIGNED. MILD INSTABILITY WAS NOTED ON EXAM BUT THERE WAS NO PATIENT COMPLAINT ABOUT STABILITY OF KNEE NOR HIS FUNCTION. NO WEAR WAS NOTED. PATELLA WAS RESURFACED AND A SLIGHTLY THICKER INSERT WAS PLACED WITHOUT DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24747717 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24365340 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD INFECTED RT TOTAL KNEE, WASHOUT POLY EXCHANGE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21123121 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 6MM INSERT WAS EXPLANTED DUE TO INSTABILITY AND REPLACED WITH A 7MM. THERE WAS NO SURGICAL DELAY. THE INSTABILITY WAS NOT RELATED TO WEAR OF THE POLYETHYLENE. THERE WAS NO REPORTED MALPOSITION OF THE COMPONENTS. NO COMPONENTS WERE UNDERSIZED DURING THE PRIMARY PROCEDURE. THE FEMUR AND TIBIA WERE NOT EXCESSIVELY RESECTED DURING THE PRIMARY SURGERY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21115336 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN UNSTABLE KNEE, AND THE SURGEON DID A POLY SWAP. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20747810 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED AND PLACED ABX SPACER FOR INFECTION. NO BROKEN PARTS. ALL PIECES RETRIEVED. NO CASE DELAY. NO COMPLAINTS. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2019; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20290575 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19990347 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR DID A WASHOUT AND SWAPPED THE POLY. NOTHING WITH THE IMPLANTS WAS OBSERVED AND THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19927510 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION OF THE PATELLA AND FBPS TO RE-IMPLANT A THINNER POLY AND RESECT MORE BONE ON PATELLA. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18749192 ↗
• MalfunctionJan 17, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE IMPLANT WAS DAMAGED DURING IMPLANTATION OR ANTERIOR LOCKING MECHANISM WAS DEFECTIVE, WOULD NOT LOCK DOWN. DOI: UNKNOWN. DOR: JANUARY 11, 2024. AFFECTED SIDE : UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525690 ↗
• MalfunctionDec 19, 2023Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT THE TAB ON THE POLY BROKE WHILE INSERTING AND IT WOULD NO LONGER LOCK. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356373 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT KNEE FELT UNSTABLE. ADDITIONAL INFORMATION RECEIVED FROM SALE REP ON 21 NOV 2023 STATED: INSTABILITY NOT RELATED TO POLY WEAR. NO REPORTED MALPOSITION OF IMPLANTS. INSERT WAS LIKELY UNDERSIZED, HE WENT UP IN THICKNESS. NO EXCESSIVE RESECTIONS IN PRIMARY SURGERY. NO DELAY. DOI: (B)(6)2022. DOR: (B)(6)2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18245654 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT KNEE REVISION DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17953750 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON BEHALF OF THE PATIENT: PATIENT SAID THAT HE HAD 2 SURGERIES THAT RESULTED IN KNEE REPLACEMENT INTO HIS LEGS. THE FIRST SURGERY HAPPENED IN 2021 HE SAID THAT WAS PERFECTLY FINE. SECOND SURGERY HAPPENED 3 MONTHS BACK HE FEEL PAIN. HE THINK THAT THE DOCTOR PUT IN INCORRECTLY WHICH IS SOMETHING WRONG WITH THE ITEM. IT WAS THE SAME DOCTOR THAT DID BOTH THE PROCEDURES. PATIENT SAID HE NO LONGER CAN WORK AND ALSO WALK, WALKS WITH THE CANE AND ALSO LOST HIS JOB.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 17001727 ↗
• InjuryApr 4, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  A PROSTHESIS SHOWS SIGNS OF LOOSENING IN THE PATIENT. IT IS NOT KNOWN WHETHER HE RELEASED THE FEMUR OR IF THE POLI DISENGAGED.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 16672785 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2021. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16609267 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SITE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16363848 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16269630 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION IN THE KNEE CALLED FOR WASH OUT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16214050 ↗
• MalfunctionDec 8, 2022Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  ADDITIONAL INFORMATION RECEIVED. A. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? THE OPERATIVE SIDE WAS LEFT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15943124 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. FULL REVISION PERFORMED LEAVING PATELLA IMPLANT IN PLACE. DOI: (B)(6) 2014, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15217105 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE POLY WAS UPSIZED DUE TO FEELING OF INSTABILITY. WENT WITH A THICKER POLY. NO SURGICAL DELAY. DOI- (B)(6) 2015; DOR- (B)(6) 2022; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14307142 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. POLY EXCHANGE WAS DONE. DOI: (B)(6) 2019, DOR: (B)(6) 2021, UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12569846 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507