ATTUNE 1516-50-508Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295052456), received between Jan 16, 2018 and Nov 10, 2025 — classified as 65 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE AND UPSIZED OF FEMORAL COMPARTMENT AND LARGER INSERT. NO PRODUCT PROBLEM WAS REPORTED. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23513624 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH LAXITY OF A TOTAL KNEE REPLACEMENT. SURGEON ELECTED TO REMOVE THE POLYETHYLENE INSERT AND IMPLANT A THICKER ONE TO SUFFICIENTLY TIGHTEN THE KNEE JOINT. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 22621325 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE REPLACEMENT. THE PATIENT DEVELOPED A LATE INFECTION. POLY WAS REMOVED WITH A WASHOUT. ANOTHER POLY WAS IMPLANTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22575349 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH REDNESS AND A WARM KNEE 3 WEEKS FROM REVISION OF THE LEFT TOTAL KNEE. SURGEON PERFORMS A THOROUGH I&D WITH INSERT EXCHANGE AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WITH NO DELAY NOR PATIENT HARM. DURING DEBRIDEMENT, SURGEON NOTICES WHAT APPEARS TO BE A CRACK IN THE ANTERIOR FEMUR AND CHOSES TO PLACE A CABLE IN THIS AREA. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Erythema

  MAUDE report 21994358 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS TIGHT IN FLEXION AND EXTENSION. DOCTOR CLEANED OUT THE SOFT TISSUE AND IMPLANTED A NEW POLY IN THE SAME SIZE. NO MENTION OF ANY ISSUE WITH THE KNEE AND TIME WAS NOT EXTENDED FOR ANY REASON. DOI: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

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

  MAUDE report 21913064 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT'S LEFT KNEE WAS REVISED ON (B)(6) 2024 DUE TO STABILITY ISSUES. SURGEON REVISED AND UPSIZED TO A THICKER POLY. ORIGINAL DATE OF IMPLANT UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 20422379 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED JOINT WAS INSTABLE AFTER PATIENT FELL. EXCHANGED ATTUNE INSERT PS RP FROM 8MM TO 10 MM.

  Patient problems: Fall; Joint Laxity

  MAUDE report 19478295 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS LOSE IN EXTENSION. SO, THE POLY WAS UPSIZED FROM AN 8MM PS/RP POLY TO A 12MM PS/RP POLY. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2020; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18902760 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF LEFT KNEE AND HAD HER POLY INSERT REPLACED WITH A THICKER SIZE FOR STABILITY. NO OTHER IMPLANTS WERE REVISED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18857185 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 18453469 ↗
• InjuryDec 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO A THICKER POLY BECAUSE OF DISLOCATION. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 18291721 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18075303 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18021203 ↗
• InjuryAug 16, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE INCORRECT INSERT SIZE WAS IMPLANTED IN (B)(6) 2022. THE PATIENT WAS EXPERIENCING DISCOMFORT AND WANTED A REVISION TO CORRECT THE INSERT. DOI: (B)(6) 2022 DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 17556370 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D). POLY WAS SWAPPED FOR SAME SIZE. DOI: (B)(6), 2023; DOR: (B)(6), 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17556103 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2019, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE TO ADDRESS LOOSENING OF HARDWARE OF RIGHT KNEE. NO MENTION OF MANUFACTURER OF COMPONENTS REVISED. RIGHT KNEE IMPLANTS THAT WERE IMPLANTED ON (B)(6) 2019 WERE DEPUY PRODUCTS.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Pain; Swelling/ Edema

  MAUDE report 17216636 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A THICKER POLY FOR STABILITY OF LIGAMENTS. THERE WAS NO LOOSENING REPORTED. THE SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16823521 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION, ALL REVISION PROSTHESIS WERE EXTRACTED AND AN ANTIBIOTIC STATIC SPACER WAS IMPLANTED. THE SAME SURGEON, PERFORMED BOTH SURGERIES. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 16655139 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT A REVISION SURGERY WAS COMPLETED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16609329 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16477437 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16459651 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16016663 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMUR WAS REVISED TO ADDRESS MID-FLEXION INSTABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16016574 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTED TKA. THE CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15799076 ↗
• InjuryOct 12, 2022Adverse 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 AS PART OF A SURGERY TO CORRECT SOME KNEE TRAUMA FOLLOWING A FALL. SURGEON ELECTED TO EXCHANGE THE POLY FOR A NEW ONE FOLLOWING THE TRAUMA REPAIRS. THERE WAS NO DAMAGE TO THE PATIENT'S KNEE IMPLANTS FOLLOWING THE FALL SHE SUFFERED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 15586978 ↗