ATTUNE 1516-50-307Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295052166), received between Apr 8, 2019 and Nov 7, 2024 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: 1. WHAT WAS THE AFFECTED SIDE? LEFT. 2. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20629554 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN. THE SURGEON DECIDED TO REVISE THE KNEE. THE FEMORAL AND TIBIAL COMPONENTS SHOWED NO SIGNS OF LOOSENING. THE PS/RP POLY WAS EXTRACTED AND EXHIBITED MINOR SIGNS OF WEAR AROUND THE BASE AND POST. THE PATELLA REMAINED IN PLACE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20087439 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS COMPLAINING OF LIMITED ROM. PATIENT WAS FOUND TO HAVE LARGE AMOUNTS OF SCAR TISSUE THAT WERE REMOVED AND A POLY EXCHANGE WAS PERFORMED. AFTER THE POLY SWAP PATIENT HAD A ROM OF ROUGHLY 0-120 DEGREES. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

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

  MAUDE report 17107208 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED INFECTION SO WAS BROUGHT IN FOR AN I&D WITH POLYETHYLENE EXCHANGE. THE SURGEON REMOVED THE SIZE 3 7MM ROTATING PLATFORM PS BEARING AND REPLACED IT WITH THE SAME SIZE AFTER A THROUGH WASHOUT OF THE KNEE. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16572035 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION AND POLY EXCHANGE COMPLETED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14361613 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOI: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13757418 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS SUTURE RUPTURE. WASHOUT WAS PERFORMED AND POLY WAS REPLACED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Wound Dehiscence

  MAUDE report 13498266 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS FALLEN AND HAD A SMALL FX IN HER MEDIAL CONDYLE. KNEE WAS UNSTABLE THROUGH OUT RANGE OF MOTION. WE UPSIZED THE FEMUR TO A 4 AND IMPLANTED A VARUS/VALGUS CONSTRAINED INSERT. COMPONENTS WERE NOT LOOSE. THIS IS ALL THE INFORMATION I HAVE ON THIS CASE. DOI: (B)(6) 2018. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Fall; Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9520097 ↗
• InjuryOct 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 27 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY AND A REVISION OF THE LEFT UNI-COMPARTMENTAL ARTHROPLASTY. THIS PC PERTAINS TO THE RIGHT KNEE. THE SURGEON UTILIZED DEPUY COMPONENTS AND TWO DEPUY CEMENTS. NO COMPLICATIONS WERE NOTED IN THE SURGICAL NOTES. ON (B)(6) 2015, THE PATIENT UNDERWENT A REVISION OF THE ATTUNE POSTERIOR STABILIZED ROTATING PLATFORM TO A SIGMA TC3 ROTATING PLATFORM COMPONENT WITH METAPHYSEAL SLEEVES TO ADDRESS AN UNSTABLE RIGHT KNEE. THE SURGEON REPORTED THAT TIBIAL COMPONENT HAD SUBLUXED POSTERIORLY DISENGAGING THE POSTERIOR POST. THE SURGEON NOTED THAT THE ROTATIONAL INSTABILITY WAS OF UNKNOWN ETIOLOGY AND DECIDED TO REMOVE BOTH THE FEMUR AND TIBIAL COMPONENTS. THERE WAS A CRACK NOTED IN THE MEDIAL CONDYLE OF THE FEMUR, WHICH WAS ¿FIXED¿ WITH 7.3 CANCELLOUS SCREW. DEPUY COMPONENTS WERE PLACED ALONG WITH 2 SMARTSET CEMENTS DURING THE REVISION. DOI: (B)(6) 2015. DOR: (B)(6) 2015 (RT KNEE).

  Patient problems: No Code Available

  MAUDE report 9210059 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, ARTHROFIBROSIS, AND DECREASED RANGE OF MOTION. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. DOI: (B)(6) 2017, DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: Fibrosis; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8935981 ↗
• InjuryApr 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2015, THE PATIENT UNDERWENT A LEFT ATTUNE PRIMARY TKA WITH REVISION OF A UNICOMPARTMENTAL PROSTHESIS OF UNKNOWN MANUFACTURER AND A RIGHT PRIMARY ATTUNE TKA WITH DEPUY CEMENT. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT REVISION DUE TO ROTATIONAL INSTABILITY CAUSING THE TIBIAL COMPONENT TO SUBLUX POSTERIORLY DISENGAGING THE POSTERIOR POST. THE SURGEON COULD NOT DETERMINE THE CAUSE OF THE ROTATIONAL INSTABILITY. THE SURGEON NOTED A SMALL FRACTURE ON THE MEDIAL CONDYLE OF THE FEMUR. DOI: (B)(6) 2015; DOR: (B)(6) 2015.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 8490981 ↗