ATTUNE 1516-20-305Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295045403), received between Dec 13, 2019 and Dec 8, 2025 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS KNEE BECAME INFLAMED AND UNSTABLE. A 3-5 MM CR POLY WAS EXCHANGED FOR A 3-8 MM LEFT POLY. SURGERY WENT WITHOUT INCIDENT. DOI: ON (B)(6) 2020, DOR: UNKNOWN, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inflammation; Joint Laxity

  MAUDE report 23749576 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR KNEE DONE BY A PRIMARY SURGEON. THE PATIENT WAS DEALING WITH KNEE INSTABILITY. THEIR KNEE WAS IN RECURVATUM. REVISING SURGEON FELT THEY NEEDED TO INCREASE THE POLY THICKNESS TO REGAIN STABILITY. A SIZE 3, 8MM MS INSERT WAS TRIALED AND FOUND TO BE STABLE. THE REAL INSERT WAS OPENED AND IMPLANTED. STABILITY WAS CONFIRMED AND CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21596852 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY OUR PATIENT THAT SHE FOUND MY NAME/NUMBER ON FDA¿S RECALL SITE. SHE WANTED TO KNOW IF HER ATTUNE KNEES IMPLANTED IN GERMANY WERE RECALLED. ATTUNE KNEES GERMANY ORIGINAL SURGERY (B)(6) 2014 BILATERAL. REVISION SURGERY IN (B)(6) LEFT SIDE IN 2019 APPROXIMATELY (B)(6) (WAS NOT SUCCESSFUL). REVISION ON LEFT (B)(6) 2020. REVISION SURGERY IN RIGHT IN (B)(6) OF 2021. PATIENT INDICATED SHE UNDERWENT BILATERAL TKAS WITH ATTUNE IMPLANTS ON (B)96) 2014 IN GERMANY. SHE UNDERWENT A REVISION OF HER LEFT KNEE IN 2019 FOR INSTABILITY AND TIBIAL TRAY LOOSENING (UNKNOWN INTERFACE OR CEMENT MFG INVOLVED). ALL IMPLANTS WERE REMOVED AND ITS UNKNOWN WHAT IMPLANTS (MANUFACTURER) WERE PLACED AS REVISION. SHE UNDERWENT A REVISION OF HER RIGHT KNEE IN (B)(6) OF 2021 FOR INSTABILITY AND TIBIAL TRAY LOOSENING (UNKNOWN INTERFACE FOR CEMENT MFG INVOLVED). ALL IMPLANTS WERE REMOVED AND ITS UNKNOWN WHAT IMPLANTS (MANUFACTURER) WERE PLACED AS REVISION. THE PATIENT IS SEEKING RECALL INFORMATION. PATIENT WAS INFORMED THE PART/LOT INFORMATION OF THE IMPLANTS PLACED IN 2014 IS NEEDED. PATIENT INDICATED SHE HAS THIS INFORMATION AND PROVIDE US WITH THIS INFORMATION. PATIEN

  Patient problems: Joint Laxity

  MAUDE report 16551662 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TO TREAT SEVERE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X1 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT¿S RIGHT KNEE WAS REVISED TO TREAT PAIN AND INSTABILITY SECONDARY TO SUSPECTED TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED PERIARTICULAR SCAR TISSUE. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION PRODUCTS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH A COMPETITOR REVISION KNEE CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 12363704 ↗
• InjuryApr 1, 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 RIGHT KNEE REVISION TO ADDRESS PAIN AND DECREASED RANGE OF MOTION. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE BOTH LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED REMOVAL OF EXCESSIVE SCAR TISSUE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2016, DOR: (B)(6) 2019, RIGHT KNEE.

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

  MAUDE report 11603122 ↗
• 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 RHEUMATOID ARTHRITIS WITH DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED PERIARTICULAR SCAR TISSUE. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA AND FEMORAL COMPONENT WERE WELL FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT RECEIVED ATTUNE REVISION COMPONENTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 10039072 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HYPOPROTEINEMIA: MALNUTRITION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Test Result

  MAUDE report 9468926 ↗