ATTUNE 1516-40-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10603295050094), received between Aug 8, 2017 and Jun 10, 2026 — classified as 54 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 59 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND SPLIT OPEN THE WOUND. THE WOUND WAS DEBRIDED. THE DEHISCENCE DID NOT ENTER THE JOINT. NO IMPLANTS WERE AFFECTED OR CHANGED. DOI: (B)(6), 2026 DOR: (B)(6), 2026 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 25458753 ↗
• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION OF KNEE. PATIENT FELL IN GARAGE AND OPENED WOUND. SURGEON CLEANED OUT AND DID A POLY SWAP. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Fluid Discharge; Joint Dislocation

  MAUDE report 23837751 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MULTIPLE JOINT EFFUSIONS PERFORMED POLY SWAP. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 22846153 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR KNEE REVISION: DATE OF EVENT: 12 JUN 2025. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 151640608. LOT NUMBER: D23113429. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE PS/FB INSERT SZ 6 8MM.

  Patient problems: Joint Laxity

  MAUDE report 22553771 ↗
• InjuryJun 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 STRETCHED THE MCL. ALL NECESSARY INFORMATION HAS BEEN PROVIDED. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 22323319 ↗
• InjuryJun 6, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT COMPLAINED ABOUT RIGHT KNEE PAIN SINCE THE ORIGINAL SURGERY ON (B)(6) 2024 BY DOCTOR AT A HOSPITAL. PATIENT RETURNED TO THE SURGEON, AND NOTHING SEEMED TO BE AN ISSUE BASED ON X-RAYS. DOCTOR SENT THE PATIENT TO SEE ANOTHER DOCTOR. THIS DOCTOR DETERMINED THE POLY HAD BECOME DISENGAGED FROM THE TIBIAL BASEPLATE. THIS DOCTOR DID A REVISION SURGERY 2 WEEKS LATER ON (B)(6) 2025 AT A HOSPITAL. BY THIS POINT THE POLY WAS COMPLETELY DISENGAGED AND FLIPPED. UPON OPENING THE CAPSULE, THE POLY HAD TURNED WITH THE POSTERIOR SIDE FACING OUTWARD. THE FEMUR AND TIBIA TRAY WERE INSPECTED, AND NO DAMAGE WAS SEEN. THE POLY HAD WEAR POSTERIORLY AND ANTERIORLY. A NEW POLY WAS INSERTED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22158045 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO JOINT INFECTION 6 MONTHS AFTER PRIMARY SURGERY. PATIENT HAS PSORIASIS ON SKIN IN AREA OF ORIGINAL INCISION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21893593 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21777997 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INFECTED KNEE WASHOUT. POLY SWAP. THE HOSPITAL DID THIS CASE WITHOUT A REP. HE WAS NOTIFIED ON OCT 16. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20693222 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: B- NO SURGERY TIME EXTENDED. C-NO ADVERSE CONSEQUENCES.

  Patient problems: Joint Laxity

  MAUDE report 20181261 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TOTAL KNEE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 19960286 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Adhesion(s)

  MAUDE report 19795184 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO EXPERIENCE PAIN AND INSTABILITY IN HIS KNEE REPLACEMENT AND SURGEON CHOOSE TO DO A KNEE REVISION TO ADDRESS. INITIAL SURGERY WAS ON (B)(6) 2022. A THICKER INSERT WAS PLACED ON (B)(6) 2023 AND A DER WAS SUBMITTED. ALL COMPONENTS WERE WELL FIXED, WELL ALIGNED, APPROPRIATELY SIZED AND WERE REMOVED ON (B)(6) 2024. JOINT LINE ALSO APPEARS APPROPRIATE. NO DELAYS NOR PATIENT HARM WAS EVIDENT. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE. (B)(4), WAS CREATED TO CAPTURE THE EVENT ON 5/18/2023.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19021107 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18731429 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. FURTHER INTRAOPERATIVE ASSESSMENT REVEALED THAT THERE WAS ASEPTIC LOOSENING OF TIBIA AT THE CEMENT TO IMPLANT INTERFACE. AS A RESULT ALL IMPLANTS WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18011094 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17362828 ↗
• MalfunctionApr 25, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE, THE POLY INSERT DID NOT ENGAGE WITH THE TIBIA. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811413 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D OF KNEE DUE TO SUSPECTED INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16427554 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IRRIGATION & DEBRIDEMENT WITH LINER EXCHANGE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16408055 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN UNSTABLE KNEE. THE CEMENT MANUFACTURER WAS UNKNOWN.. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16148419 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED DUE TO INFECTION. NO SURGICAL DELAY WAS REPORTED. DOI: UNK. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15924452 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD (B)(6) 2022. REVISION OPERATIVE NOTES (B)(6) 2022 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO CHRONIC INSTABILITY WITH LOOSE FEMORAL AND TIBIAL COMPONENTS. UPON ENTERING THE JOINT, CHRONIC INFLAMMATION AND SCARRING WERE ENCOUNTERED AND DEBRIDED. FEMORAL COMPONENT WAS NOTED TO BE LOOSE AT THE BONE TO CEMENT INTERFACE, A LARGE METAPHYSEAL BONE DEFECT. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Adhesion(s); Inflammation; Joint Laxity

  MAUDE report 15583572 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMORAL COMPONENT REVISION WAS PERFORMED DUE TO LACK OF RANGE OF MOTION CAUSED BY ARTHROFIBROSIS. FEMUR WAS REMOVED AND DOWNSIZED TO A 5 FEMUR WITH CEMENTED STEM AND AUGMENTS. A 6MM CRS FB POLY WAS SELECTED AND IMPLANTED. SALES REP HAVE NO FURTHER INFORMATION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 15502385 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO REDUCED ROM. THE KNEE WAS DEBRIDED AND A 10MM INSERT. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 14518645 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE FIRST PAIN WHICH OCCURRED AFTER THE FIRST SURGERY ON UNKNOWN DATE. THIS PC REPORTS ABOUT THE SECOND PAIN WHICH OCCURRED ON (B)(6) 2021 IN THE REGULAR HEALTH FOLLOW-UP FOR THE KNEE. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY (TKA) SURGERY FOR KNEE OSTEOARTHRITIS WITH THE KNEE FEMORAL COMPONENT, TIBIAL TRAY, KNEE TIBIAL INSERT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. TWO MONTHS AFTER SURGERY, ON UNKNOWN THE PATIENT FELT PAIN AND RECEIVED THE FIRST TREATMENT. AFTER THAT ON (B)(6) 2021, THE PATIENT VISITED THE HOSPITAL FOR REGULAR HEALTH FOLLOW-UP FOR THE KNEE, THE PATIENT FELT PAIN WHILE SITTING ON A HOSPITAL CHAIR. WHEN THE SURGEON EXAMINED THE KNEE, IT WAS CONFIRMED THAT BLOOD HAD ACCUMULATED, AND THE PATIENT WAS TREATED TO REMOVE THE SECOND BLOOD. THE TREATMENT WAS COMPLETED SUCCESSFULLY. DOI: UNKNOWN. DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Hematoma; Pain

  MAUDE report 12554386 ↗

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