ATTUNE 1516-40-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295049968), received between Jun 22, 2017 and Sep 24, 2026 — classified as 44 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that surgeon revised for instability. No patient complications. No further information.DOI : Unknown.DOR: (b)(6) 2026.Affected side-Left knee.

  Patient problems: Joint Laxity

  MAUDE report 50878003 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS KNEE LAXITY AND PATIENT NEEDED A THICKER POLY. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24820643 ↗
• InjuryAug 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 SOME INSTABILITY. SURGEON REMOVED OLD POLY AND REPLACED WITH A THICKER POLY. DOI: (B)(6) 2001. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22783534 ↗
• 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 DUE TO INFECTION. IMPLANTS WERE REMOVED; THERE WAS LOOSENING OF THE TIBIAL TRAY AT CEMENT TO THE IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22530873 ↗
• InjuryJun 18, 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. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22285514 ↗
• InjuryMay 21, 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 LOOSE COMPONENTS FROM CHRONIC INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 22063355 ↗
• InjuryOct 9, 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 PAINFUL KNEE. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20406922 ↗
• MalfunctionJul 31, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  ADDITIONAL INFORMATION WAS RECEIVED: SALES REP CONFIRMED THE FOLLOWING: "THE PHOTO BELOW SHOWS WHAT THE NURSE SAW WHEN SHE OPENED THE IMPLANT BOX. THIS IS THOUGHT TO BE THE YELLOW TEXT IN THE QUESTION". TEXT IN YELLOW: "DEVICE WAS FOUND WITH THAT DAMAGE WHEN IT WAS OPEN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19871620 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN WITH COMPLAINTS OF AN UNSTABLE KNEE. THE SURGEON OPTED FOR A POLY SWAP WITH TWO SIZES THICKER IN POLY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19826914 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024 , AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19654129 ↗
• InjuryJan 19, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT PREVIOUS SURGEON IMPLANTED A PS BEARING WHEN THEY USED A CR FEMUR. POLY WAS NOT COMPATIBLE. EXCHANGED FOR A MS POLY. DOI- (B)(6) 2019. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18541800 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND LOOSENING OF FEMUR AT BONE TO CEMENT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN, DOR: DEC 11, 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18360090 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH CRS INSERT IMPLANTED DUE TO INSTABILITY. THERE WAS NO LOOSENING REPORTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16770276 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: MAR 30, 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16760789 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 24 FEB 2023. PATIENT RECEIVED A RIGHT PRIMARY ATTUNE KNEE. THE PATELLA WAS RESURFACED, AND UNKNOWN CEMENT WAS UTILIZED. MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT A FAILED TKA. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED SYNOVITIS AND FOREIGN BODY REACTION. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND HAD MIGRATED INTO VARUS. THE SURGEON NOTES TIBIAL BONE LOSS AFTER THE TRAY WAS REMOVED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION KNEE CONSTRUCT. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A TC3 REVISION KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Foreign Body Reaction; Synovitis

  MAUDE report 16536510 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15708278 ↗
• InjurySep 26, 2022Loss of or Failure to Bond; Noise, Audible; Loss of or Failure to Bond; Noise, Audible

  A CALL FROM A CUSTOMER WAS RECEIVED WANTED TO MAKE A COMPLAINT ABOUT THE DEPUY SYNTHES BECAUSE THE FIRST ONE FAILS. THE TIBIA WAS REMOVED AND UNDERGONE A SURGERY. THE PATIENT CALLED TO CHECK IF THEY EVER SETTLED OUT OF COURT OR IF THE PATIENT NEEDED TO GET AN ATTORNEY. SPOKE WITH PATIENT ON (B)(6) 2022. PATIENT STATES HER PRIMARY WAS DONE IN (B)(6) 2017. SHE HAD ATTUNE IMPLANTS PLACED AT THAT TIME. SHE WAS WALKING IN THE YARD WHEN SHE HEARD A POP AND FELL TO THE GROUND. SHE WAS THEN REVISED ON (B)(6) 2022 DUE TO A LOOSE TRAY. THE INSERT AND TRAY WERE REVISED. DOI: (B)(6) 2017; DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Fall; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 15485710 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH POSSIBLE INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15347381 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO LOOSENING AND NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15274878 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO LIMITED FLEXION. NO SURGICAL DELAY REPORTED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 13860505 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE TKA TO TREAT END-STAGE ARTHRITIS WITH VARUS ALIGNMENT. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, SWELLING, AND INCREASED VARUS DEFORMITY SECONDARY TO LOOSENING AND COLLAPSE OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED SYNOVITIS AND SCAR TISSUE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE SURGEON NOTES THERE WERE SOME TIBIAL CAVITARY DEFECTS IDENTIFIED AFTER THE TIBIAL TRAY WAS EXPLANTED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA AND FEMORAL COMPONENTS WERE WELL-FIXED AND RETAINED. THE PATIENT WAS REVISED WITH ATTUNE TIBIAL REVISION COMPONENTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 13657151 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN, INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13506668 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MILD INSTABILITY. POLY EXCHANGE WAS PERFORMED. STD TECHNIQUE WAS UTILIZED WITH NO ELEVATION OF JOINT LINE, NO WEAR NOTED, ALIGNMENT WAS GOOD AND IMPLANTS WERE APPROPRIATELY SIZED. ALL INFORMATION WERE PROVIDED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13251219 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 01 MAY 2020. ON (B)(6) 2016, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS OF THE LEFT KNEE. DEPUY COMPONENTS AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. DOI: (B)(6) 2016; DOR: (B)(6) 2020; (LEFT KNEE).

  Patient problems: Joint Laxity; Pain

  MAUDE report 13111542 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  QUESTIONS: A. WHAT WAS THE REASON FOR I&D? WAS THERE AN INFECTION? B. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS THAT WILL LEAD TO THE REVISION SURGERY?" ANSWER: "WOUND DEHISCENCE, NO OTHER INFORMATION AVAILABLE".

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 12527310 ↗

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