ATTUNE 1516-50-906Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295052999), received between Aug 30, 2019 and Jan 21, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 16, 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.

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

  IT WAS REPORTED THAT THE PATIENT HAS INFECTED KNEE. JOINT WAS WASHED OUT, LINER EXCHANGED AND ANTIBIOTIC BEADS PLACED. NO DELAYS. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24130257 ↗
• InjuryJul 15, 2025Adverse 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 MECHANICAL INSTABILITY LEADING TO PAIN. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22507382 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED FOR PAIN AND POLY WAS EXCHANGED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19712019 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18141445 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INFECTED AND A WASHOUT WAS PERFORMED BY THE SURGEON. WASHOUT THE KNEE, EXPLANTED THE OLD INSERT. IMPLANTED A NEW INSERT AFTER WASHOUT WAS COMPLETE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18046201 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16225859 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXCESS BLEEDING 24 HOURS AFTER SURGERY, SO SURGEON WENT IN TO MAKE SURE THERE WEREN¿T ANY ARTERIAL BLEEDS. WHILE HE WAS IN THE CAPSUL HE PUT A NEW POLY INSERT IN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16023781 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION FOLLOWING TKA. THERE WAS NO LOOSENING EXPERIENCED AND THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15529367 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVED AN ATTUNE TKA DUE TO INFECTION. DOI: UNK; DOR: UNK; UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15249688 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ACUTE SWELLING. SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT WITH REMOVAL OF COMPONENTS AND PLACEMENT OF ANTIBIOTIC SPACER WITH ATTUNE PS FEMUR AND RP INSERT. THERE WAS NO INDICATION OF GROSS INFECTION. THE KNEE WAS FILLED WITH OLD BLOOD. ALL COMPONENTS WERE REMOVED EXCEPT THE PATELLA. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 11516736 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS JOINT INSTABILITY AND ASEPTIC LOOSENING OF THE TIBIAL TRAY DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2020. (LEFT KNEE) TREATMENT: REVISION OF TIBIAL TRAY AND INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11359389 ↗
• InjuryJul 9, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PATIENT COMPLAINS OF INSTABILITY, SUSPECTED UNDERSIZED INSERT. INSERT EXCHANGED FROM A SIZE 9 6MM TO SIZE 9 10MM.

  Patient problems: No Code Available

  MAUDE report 10251276 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A PRIMARY LEFT ATTUNE AND TO TREAT PAIN SECONDARY TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 3 WAS UTILIZED. THERE SURGEON NOTES THERE WAS SEVERE TRICOMPARTMENTAL ARTICULAR CARTILAGE LOSS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT TIBIAL PAIN AND WALKING DIFFICULTY SECONDARY TO ACUTE AND CHRONIC INFLAMMATION. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED SIGNIFICANT GREY TINGED PSEUDO SYNOVIUM, SYNOVITIS, AND DENSE FIBROSIS. PATHOLOGY OF THE EXCISED SYNOVIUM IDENTIFIED ACUTE AND CHRONIC INFLAMMATORY MARKERS INDICATING HYPERSENSITIVITY AND FOREIGN BODY REACTION. PATHOLOGY REPORTS DID NOT CONFIRM THE PRESENCE OF INFECTION. THE SURGEON DECIDED TO REVISE ALL COMPONENTS TO A DEPUY ANTIBIOTIC SPACER. THERE WERE NO REPORTED PRODUCT DEFECTS FOR THE PATELLA, FEMORAL COMPONENT, TIBIAL TRAY, OR TIBIAL INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; No Code Available; Pain; Synovitis

  MAUDE report 10234212 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT ALL CONFIRMS THAT THE ORIGINAL CLINICAL ADVERSE EVENT WAS REPORTED IN ERROR FOR THIS STUDY SUBJECT. THE INFORMATION APPLIED TO A DIFFERENT STUDY SUBJECT, WHICH IS CONFIRMED TO HAVE BEEN ADDRESSED. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS CURRENT COMPLAINT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9764914 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED HYPERTROPHIC SYNOVIUM WITH A BIT OF METAL TINGE. THE PATELLA COMPONENT WAS NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT KNEE.

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

  MAUDE report 9327942 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). MR (B)(6) IMPLANTED A RIGHT PRIMARY ATTUNE INTO (B)(6) YEAR OLD MALE IN (B)(6) 2016. POST OP WAS FINE, BUT HAS PRESENTED IN 2019 AND X-RAYS SHOW TIBIA HAS TIPPED INTO A GREATER DEGREE OF VARUS ALIGNMENT WITH MEDIAL PLATEAU DEFICIENCY. PRIMARY COMPONENTS WERE A SZ 9 PS FEMUR, SZ 8 RP TIBIA AND SZ 9, 6MM RP PS INSERT. REVISION PLAN WAS TO REMOVE THE TIBIAL BASE PLATE AND INSERT, REPLACE WITH REVISION RP TIBIA WITH STEM +/- SLEEVE, AND ANOTHER PS RP INSERT IN ORDER TO RETAIN FEMORAL COMPONENT IF WELL FIXED AND BALANCED. PLANNED TO DO A PATELLA COMPONENT AS WELL, AS X-RAY SUGGESTED PROGRESSIVE ARTHRITIS IN PATELLA. PATIENT WAS A WELL BUILT, MUSCULAR MALE. TIBIA CEMENT MANTLE WAS BROKEN WITH LIGHT OSTEOTOME ON LATERAL SIDE, WAS LOOSE ON MEDIAL SIDE AND LIFTED OUT WITH NO CEMENT ATTACHED. THERE WAS OVER 5MM OF BONE LOSS ON MEDIAL SIDE, WHICH MR (B)(6) DESCRIBED AS LYSIS. REVISED TO A REVISION SIZE 8 RP TIBIA WITH 29MM FULLY COATED SLEEVE AND 110X12MM PRESSFIT STEM WITH SZ 9, 6MM RP PS INSERT. ALSO 41MM ANATOMIC PATELLA. MR (B)(6) USED SOME ADDITIONAL BONE GRAFTING AND CEMENT TO FILL REMAINDER OF MEDIAL DEFECT. MR (B)(6) HAD MOVED HIS PRIMARY KNEE BUSINESS AWAY FROM ATTUNE AT THE

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8951981 ↗