ATTUNE 1516-20-906Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295046134), received between Dec 20, 2018 and Dec 3, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE IMPLANT WAS CHIPPED. IT DID NOT HAPPEN IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835924 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED DUE TO POSSIBLE INFECTION/ ASEPTIC LOOSENING. DOI: (B)(6) 2017. DOE: 04 JUL 2024.

  Patient problems: Unspecified Infection

  MAUDE report 19743096 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD AD (B)(6) 2023 WERE REVIEWED BY CLINICIAN. ON (B)(6) 2023 THE PATIENT HAD A REVISION RIGHT TOTAL KNEE REPLACEMENT TO ADDRESS LIGAMENTOUS LAXITY OF RIGHT KNEE. THE INDICATIONS FOR SURGERY INCLUDED PAIN AND LIGAMENTOUS LAXITY. THE FEMORAL AND TIBIAL TRAY COMPONENTS WERE FOUND TO BE WELL FIXED AND RETAINED. THE INSERT WAS REVISED. DEPUY INSERT WAS IMPLANTED DURING THIS PROCEDURE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18362669 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A ATTUNE KNEE DUE TO INFECTION. THE CR FB POLY WAS REMOVED AND A DEBRIDEMENT AND WASHOUT WAS PERFORMED. A NEW 6MM POLY WAS THEN IMPLANTED. PATIENT WAS A MALE, LEFT SIDE. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2021. PATIENT WILL BE MONITORED TO SEE IF THIS RESOLVES THE INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2022 ; UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13341551 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2019: PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OA. THE PATELLA WASN¿T RESURFACED AND CEMENT MFG IS DEPUY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. (B)(6) 2020: PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN WITH AMBULATION. THERE WERE NO CLINICAL SIGNS OF INFECTION. THE TIBIAL TRAY WAS NOTED TO BE GROSSLY LOOSE AT THE CEMENT TO IMPLANT INTERFACE. LATERAL TIBIAL SUBSIDENCE WAS ALSO NOTED. THERE WERE NO ALLEGED PRODUCT DEFICIENCIES WITH THE FEMORAL COMPONENT OR TIBIAL INSERT. COMPETITOR PRODUCTS WERE PLACED AT REVISION. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12533006 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO POSTTRAUMATIC ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR CEMENT. DOI: (B)(6) 2016. DOR: NO REVISION, (RT KNEE).

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9547707 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED (B)(6) 2019. THE PATIENT UNDERWENT A RIGHT KNEE TIBIAL INSERT EXCHANGE, IRRIGATION AND DEBRIDEMENT, MANIPULATION, AND PLACEMENT OF ANTIBITOIC BEADS DUE TO CELLULITIS, SUSPECTED POST-OPERATIVE WOUND INFECTION, PATELLA TENDON RUPTURE, FALL, STIFFNESS, DECREASED RANGE OF MOTION, EFFUSION, AND HEMATOMA. THE SURGEON NOTED HE DID NOT REPAIR THE PATELLA TENDON TEAR DUE TO THE FACT THERE IS SUSPICION OF INFECTION AND DID NOT WANT TO HAVE FOREIGN BODIES THAT COULD PERPETUATE FURTHER INFECTION. THE SURGEON OBTAINED INTRA-OPERATIVE CULTURES TO DETERMINE PRESENCE OF WOUND INFECTION. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Edema; Hematoma; Limited Mobility Of The Implanted Joint; No Code Available; Unspecified Infection

  MAUDE report 9260722 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8185571 ↗