ATTUNE 1516-50-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295052326), received between Jun 21, 2018 and Sep 21, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Joint Laxity

  MAUDE report 50847139 ↗
• InjuryJun 9, 2026Adverse 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 25448598 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AUGUST 17, 2022, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2025, THE AGENCY CONTACTED THE SALES REP STATING THAT THE PATIENT HAD DEVELOPED A POSTOPERATIVE INFECTION, AND ON (B)(6) 2025, DEBRIDEMENT AND REPLACING THE INSERT WERE PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22817310 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT NEEDED TO BE REVISED DUE TO GLOBAL INSTABILITY. SURGEON FELT IT BEST TO CONVERT TO A HINGED PROSTHESIS. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22680707 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN , DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21971748 ↗
• InjuryDec 11, 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 LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT HAD A SLIP AT A WATER PARK OVER THE SUMMER AND PRESENTED WITH KNEE PAIN. THE PATIENT HAD A PREVIOUS TKA PROCEDURE DONE BY ANOTHER SURGEON BACK IN 2018. WHEN BEING EXAMINED FOR THE KNEE PAIN, IT WAS DISCOVERED THAT THERE WAS SOME IMPLANT LOOSENING DUE TO THE FALL SHE HAD TAKEN. WHEN WE GOT IN THERE AND OPENED THE CAPSULE THE TIBIAL IMPLANT WAS LOOSE, AND NEEDED TO BE REPLACED WITH A REVISION TIBIAL TRAY, SLEEVE, AND STEM FOR BETTER FIXATION. THE REVISION PROCEDURE WAS COMPLETED AND THE PATIENT NOW HAS A STABLE KNEE REPLACEMENT ONCE AGAIN. WE ALSO REPLACED THE POLYETHYLENE FOR A THICKER AND MORE STABLE FEEL. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 20904084 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A KNEE REPLACEMENT AT ANOTHER HOSPITAL AND LACKED RANGE OF MOTION . SURGEON REMOVED THE FEMUR, CUT THE DISTAL FEMUR AND PUT IN ATTUNE POLY 4X8. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20413073 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18269686 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: ON (B)(6) 2021, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17948336 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD RESECTION FOR STAPH EPI INFECTION. DOI: (B)(6), 2020, DOR: (B)(6), 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17803949 ↗
• InjurySep 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PRIMARY SURGERY WAS PERFORMED WITH THE IMPLANT IN QUESTION. ON (B)(6) 2023, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE INSERT DUE TO THE FEMORAL ANTERIOR DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI:(B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17689430 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND ALL COMPONENTS WERE REMOVED AND A SPACED PLACED. NO PATIENT HARM OCCURRED. A POLY EXCHANGE AND I&D WAS PERFORMED ON (B)(6) 2022. DOI- (B)(6) 2022; DOR- (B)(6) 2022; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15902529 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT ON THE (B)(6) 2022 WHERE ATTUNE REVISION IMPLANTS WERE UTILISED. THE PATIENT PRESENTED FOR A REVISION PROCEDURE ON THE (B)(6) 2022 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 15579743 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SOME SIGNS OF INFECTION. THE SURGEON WANTED TO DO A POLY EXCHANGE AND A WASH OUT OF THE KNEE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15232861 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO STABILITY ISSUES WITH THE KNEE. PATIENT HAD PREVIOUS REVISION IN 2016 WITH ANOTHER SURGEON WHERE POLY EXCHANGE WAS PERFORMED. NO INFORMATION REGARDING THE ORIGINAL SURGERY. DOI: UNKNOWN 1ST REVISION: (B)(6) 2016 (TIBIAL INSERT). 2ND REVISION: (B)(6) 2021 (ALL IMPLANTS). RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11787182 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS INSTABILITY AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE RESECTION OF EXTENSIVE SCAR TISSUE. THE SURGEON ALSO NOTE THE TIBIAL TRAY TO BE IN APPROXIMATELY 45 DEGREES OF VALGUS WITH MASSIVE MEDIAL BONE LOSS. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 11758330 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND THE PATIENT HAD A SECOND REVISION OF HER RIGHT KNEE FOR PAIN. ALL IMPLANTS WERE REVISED - EXCEPT THE PATELLA. COMPETITOR PRODUCTS WERE IMPLANTED. DOI: (B)(6) 2016 (TIBIAL COMPONENT); DOI: (B)(6) 2017 (TIBIAL INSERT, FEMORAL COMPONENT, AND CEMENT); DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 10929052 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED RIGHT KNEE REVISION DUE TO PAIN AND FLEXION INSTABILITY SECONDARY TO LOOSENING AND SUBSIDENCE OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED THAT THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE PATELLA WAS WELL FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT RECEIVED COMPETITOR REVISION COMPONENTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 20190. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10039500 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A SECOND REVISION DUE TO PAIN, POSSIBLE TIBIAL LOOSENING, AND FIBROSIS. DEPUY CEMENT WAS USED DURING THE FIRST REVISION OPERATION. THERE WAS NO EVIDENCE OF INFECTION. THE WAS NO MENTION OF LOOSENING WITHIN THE REVISION OPERATIVE PROCEDURE NOTE. DEFINITIVE COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2016; DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9336210 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2015; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9273455 ↗
• InjuryAug 23, 2019Loss 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

  PATIENT HAS SUBSIDED/LOOSE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. SIZE 4 ATTUNE TRAY EXPLANTED ALONG WITH 4/10 RP POLY. REVISED WITH ATTUNE REVISION SIZE 3 TRAY. 37 SLEEVE & 4/12 POLY. DOI: (B)(6) 2017. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Necrosis; No Code Available; Pain; Scarring

  MAUDE report 8925639 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8874878 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8357588 ↗
• InjuryNov 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN AND DISCOMFORT.

  Patient problems: Discomfort; Pain

  MAUDE report 8091187 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS WOUND INFECTION. PRESENTED WITH OPEN WOUND WHERE INCISION SITE WAS . DEBRIDEMENT AND POLY SWAP DONE. DOI: (B)(6) 2018. DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7975201 ↗