ATTUNE 1516-20-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295045557), received between Mar 14, 2018 and Jul 10, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT UNSTABLE PRIMARY. IT WAS STATED THAT TIBIA WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25780501 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RIGHT KNEE REVISION ON (B)(6) 2024, HAD A POLY EXCHANGE DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DATE OF IMPLANT WAS (B)(6) 2020

  Patient problems: Unspecified Infection

  MAUDE report 20676092 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT KNEE WAS LOOSE, HAD DISCOMFORT AND MAY HAVE RUPTURED HIS PCL. IT IS UNKNOWN HOW LONG PATIENT HAD DISCOMFORT FOR. SURGEONS PLAN WAS TO REMOVE THE POLYETHYLENE INSERT AND REPLACE WITH A MEDIAL STABILIZED INSERT TO COUNTERACT THE POSSIBLE RUPTURED PCL. THIS WAS IN FACT WHAT THE SURGEON DID. DOI- (B)(6) 2018, DOR- (B)(6) 2024, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 20279003 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20248553 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE BLOOD LOSS ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: ON (B)(6) 2018. DATE OF EVENT: ON (B)(6) 2018. (LEFT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16609049 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A RIGHT TKA ON (B)(6) 1015 INVOLVING ATTUNE IMPLANTS AND DEPUY SYNTHES BONE CEMENT WITH NO COMPLICATIONS. THE PATELLA WAS RESURFACED AS WELL. ON (B)(6) 2022, SHE UNDERWENT A RIGHT REVISION FOR LOOSENING OF THE TIBIAL TRAY AT THE IMPLANT TO CEMENT INTERFACE AND SCARRING WAS NOTED. DOI: (B)(6) 2015, DOR: (B)(6) 2022, (RIGHT KNEE).

  Patient problems: Scar Tissue; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 15138333 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS ACHING, INSTABILITY AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. CEMENT WAS GREEN IN COLOR NO MANUFACTURE KNOWN. SURGEON NOTED KNEE WAS UNSTABLE AND PCL WAS FIBROUS BUT NOT COMPETENT. DOI: (B)(6) 2012 - DOR: (B)(6) 2021 (LEFT KNEE).

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

  MAUDE report 13043279 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. REVISION OF TIBIAL INSERT ONLY. DATE OF IMPLANT: (B)(6) 2020; DATE OF REVISION: (B)(6) 2021; (LEFT KNEE).

  Patient problems: Joint Laxity; Synovitis

  MAUDE report 12770101 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED THAT PATIENT WAS EXPERIENCING PAIN AND STIFFNESS PRIOR TO REVISION FOR LOOSENING OF THE TIBIAL COMPONENT DATE OF IMPLANTATION: (B)(6) 2014. (RIGHT KNEE). TREATMENT: MEDICAL INTERVENTION/MODIFICATION (UNSPECIFIED) SURGICAL REVISION OF STUDY KNEE, ON (B)(6) 2020, WITH FEMUR, TIBIAL TRAY, PATELLA AND TIBIAL INSERT ALL REVISED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 11877592 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHTNESS IN FLEXION. THE PLAN WAS TO DOWNSIZE THE POLY FROM THE SIZE 4X8 MM BUT LEFT EXTENSION WAS TO LOOSE. SURGEON ENDED UP CLEANING THE SCAR TISSUE AND BELIEVE ENDED RELEASING THE PCL SLIGHTLY. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Muscular Rigidity

  MAUDE report 11744811 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY, UNDERWENT POLY SWAP. ALSO, THE SURGEON RESURFACED THE PATELLA SINCE THE PATELLA WAS NOT RESURFACED ON THE INITIAL SURGERY. DOI: (B)(6) 2016. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9747148 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION LEFT TOTAL KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF REVISION: (B)(6) 2019; (LEFT KNEE). INSERT REVISED ONLY.

  Patient problems: No Code Available

  MAUDE report 9607133 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND INSTABILITY. DOI: (B)(6) 2016; DOR: (B)(6) 2018 (RT KNEE).

  Patient problems: Injury; Joint Disorder; No Code Available

  MAUDE report 9452812 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. THE SURGEON DID AN I&D AND POLY SWAP. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 9417264 ↗
• InjurySep 9, 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 AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014, DOR: (B)(6) 2016 , RIGHT KNEE.

  Patient problems: Fibrosis; No Code Available; Pain

  MAUDE report 8977690 ↗
• InjuryMar 14, 2018Insufficient Device Problem Information

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE MEDICAL RECORDS INDICATE THE PATIENT WAS IMPLANTED WITH DEPUY IMPLANTS ON (B)(6) 2015 AND REVISED ON (B)(6) 2016. NO PRIMARY OR REVISION OPERATIVE NOTES WERE PROVIDED. THE KNOWN DEPUY IMPLANTS WERE FOUND OFF THE ATTACHED HOSPITAL BILLING INFORMATION WHICH INDICATED DEPUY IMPLANTS WERE PLACED AT PRIMARY AND REVISION. COMPETITOR CEMENT WAS USED A PRIMARY. RADIOLOGY NOTE FROM (B)(6) 2016 INDICATED LEFT KNEE PAIN. THE REVISION OPERATIVE NOTE FINDINGS/REASON FOR REVISION IS UNKNOWN. ANALYST REVIEWED THE ATTACHED X-RAYS INDICATING THE PRIMARY IMPLANTS APPEAR TO BE DEPUY IMPLANTS. DOI: (B)(6) 2015. DOR: (B)(6) 2016 (LEFT KNEE).

  Patient problems: Pain

  MAUDE report 7337942 ↗