ATTUNE 1516-20-507Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295045663), received between Jun 6, 2018 and Apr 11, 2026 — classified as 32 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 reports).

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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIGHT FLEXION GAP FROM RIGHT TKA WITH ATTUNE IMPLANTS, POLY SWAP WITH SIZE 5 CR FB 7MM THICK INSERT TO SIZE 5 MS CR FB 5MM THICK. NO DELAY IN CASE. NO LOOSE COMPONENTS. DOI: (B)(6) 2020, DOR: (B)(6) 2026, AFFECTED SIDE-UNKNOWN.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 24846198 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION DUE TO INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 17197460 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DARTMOUTH BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 11.9 MONTHS. REASON FOR REVISION: SEPSIS, PAINFUL

  Patient problems: Pain; Sepsis

  MAUDE report 16378854 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(4) BIOMEDICAL ENGINEERING CENTER FOR ORTHOPEDICS ANALYSIS OF DEPUY SYNTHES ATTUNE KNEE SYSTEM IMPLANT COMPONENTS AND ASSOCIATED TISSUES AND FLUIDS: AN ATTUNE AOX INSERT WAS IN VIVO FOR A TOTAL OF 40.1 MONTHS. REASON FOR REVISION: INFECTION".

  Patient problems: Unspecified Infection

  MAUDE report 16378215 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTER THAT THE KNEE WAS GLOBALLY UNSTABLE. SURGEON TOOK THE OLD POLY OUT, DID SOME RELEASES AND PUT A NEW POLY IN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN . DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15915003 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLY SWAP DUE TO INSTABILITY. THERE WAS NO DELAY IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15734241 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. (LEFT SIDE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Adhesion(s); Extraskeletal ossification; Loss of Range of Motion; Muscular Rigidity; Pain; Synovitis

  MAUDE report 15679603 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR WHERE AN RIGHT ATTUNE CR FIXED IMPLANT WAS UTILISED (B)(6) 2017 ((B)(6) HOSPITAL). IT APPEARS THAT A MPFL WAS REPAIRED AT THE TIME. THE ORIGINAL REASON FOR SURGERY IS UNKNOWN. PATIENT HAS PRESENTED WITH A PAINFUL STIFF KNEE WITH A LIMITED ROM OF AROUND 15 TO 40 DEGREES. PATIENT HAS HAD A NUMBER OF TESTS, SCANS AND X RAYS TO DETERMINE THE ROOT CAUSE BUT THIS HAS NOT BEEN CONCLUSIVE ON OPENING THE KNEE ((B)(6) HOSPITAL (B)(6) 2022) THE KNEE APPEARED WELL FIXED. THE GUTTERS WERE CLEARED. IT APPEARED THAT THE FLEXION GAP WAS VERY TIGHT AND THE PCL WAS RELEASED. SCARE TISSUE WAS REMOVED POSTERIORLY. THE 7MM POLY WAS REMOVED AND REPLACED WITH A 7MM POLY. THE PATIENT HAD APPROXIMATELY 0 TO 110 DEGREES OF PASSIVE ROM ON THE TABLE.

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

  MAUDE report 15568790 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DO TS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. LEFT KNEE. INSERT WAS REMOVED. DEPUY PRODUCTS: 150670004 9666994; 150400125 9675648; 151820032 9357705; 151620507 J9796P.

  Patient problems: Joint Laxity; Swelling/ Edema

  MAUDE report 14958085 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI: (B)(6) 2018. PATIENT RECEIVED A LEFT PRIMARY ATTUNE TKA TO TREAT SEVERE END-STAGE ARTHRITIS WITH VALGUS DEFORMITY. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE SURGEON NOTES THAT EXTENSIVE NATURAL SYNOVITIS NEEDED TO BE DEBRIDED BEFORE PRIMARY IMPLANTATION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. MUA: (B)(6) 2018 PATIENT RECEIVED KNEE MANIPULATION UNDER ANESTHESIA FOR UNKNOWN REASONS. NO FURTHER INFORMATION AVAILABLE. DOR (B)(6) 2021. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN, SWELLING, STIFFNESS, AND INSTABILITY SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND DEBRIDED SCAR TISSUE. THE TIBIAL TRAY WAS LOOSE AT AN UNKNOWN INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. THE PATELLA WAS RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT SECURED WITH COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. MUA: (B)(6) 2021. PATIENT RECEIVED A MANIPULATION UNDER ANESTHESIA FOR UNKNOWN REASONS. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2014. DOE: (B)

  Patient problems: Adhesion(s); Joint Laxity; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 13826302 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE TKA TO TREAT SEVERE END-STAGE ARTHRITIS WITH VALGUS DEFORMITY. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE SURGEON NOTES THAT EXTENSIVE NATURAL SYNOVITIS NEEDED TO BE DEBRIDED BEFORE PRIMARY IMPLANTATION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED KNEE MANIPULATION UNDER ANESTHESIA FOR UNKNOWN REASONS. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6), 2018. DOE: (B)(6), 2018 (MUA). DOR (B)(6), 2021 ( (B)(4) REVISION TO COMPETITOR CONSTRUCT WITH RETAINED PATELLA). DOE: (B)(6), 2021 (MUA). LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 13826181 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D AND POLY EXCHANGE WERE DONE DUE TO INFECTION. NO ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13262190 ↗
• InjuryOct 6, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DR. X EXPLANTED CRFB 5X7MM POLY FROM THE PATIENT DUE TO WEAR ON THE MEDIAL SIDE. HE REPLACED THIS POLY AFTER A THOROUGH WASHOUT AND INCREASED SIZE TO CR FB 5X12MM. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12582925 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, SWELLING, ASEPTIC LOOSENING AND INSTABILITY. UPON ENTERING THE JOINT, SYNOVITIS AND SCARRING WAS ENCOUNTERED AND REMOVED. THE TIBIAL COMPONENT WAS NOTED TO BE SUBSIDED AND LOOSE AT THE CEMENT TO IMPLANT INTERFACE. NO INDICATED DEFICIENCY RELATING TO THE INSERT, PATELLA OR FEMORAL COMPONENT ¿ HOWEVER, THEY WERE ALL REVISED. COMPETITOR PRODUCTS IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12319106 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11888551 ↗
• InjuryFeb 24, 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 NOT RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN, INSTABILITY, ADHESIONS, AND TIBIAL TRAY MISPOSITIONING AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON REVISED ALL COMPONENTS AND RESURFACED THE PATELLA. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND COMPETITOR CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015; DOR: (B)(6) 2018; RIGHT KNEE.

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

  MAUDE report 11374862 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY WITH EXTENSIVE LIGAMENTOUS LAXITY. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF REVISION: (B)(6) 2020, (RIGHT KNEE). TREATMENT: TIBIAL INSERT REVISED. ADDITIONAL INFORMATION RECEIVED: DOR (B)(6) 2020: PATIENT RECEIVED A RIGHT KNEE REVISION OF THE TIBIAL INSERT TO TREAT PAIN AND INSTABILITY SECONDARY TO UNSPECIFIED INTERNAL DERANGEMENT OF THE KNEE. UPON ENTERING THE JOINT, MEDIAL COMPARTMENT SCAR TISSUE WAS DEBRIDED. THE SURGEON NOTES THE KNEE HAD INTOLERABLE MEDIAL LAXITY WITH HYPEREXTENSION. THE WAS NO NOTED WEAR OR DYSFUNCTION OF THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A SIZE 5/14 MM CR FB INSERT THAT PROVIDED EXCELLENT ROM AND STABILITY. ALL OTHER KNEE COMPONENTS WERE RETAINED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2020, DOR (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 11342270 ↗
• InjuryDec 3, 2020Adverse 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, STIFFNESS, NICKEL ALLERGY, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. THE PATELLAR COMPONENT WAS RETAINED. COMPETITOR PRODUCTS WERE IMPLANTED WITH COMPETITOR CEMENT. THERE IS NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; Pain

  MAUDE report 10937348 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS NOT BALANCED WELL. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 10896901 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT A FLEXION CONTRACTURE OF 5 DEGREES. UPON ENTERING THE JOINT, THE SURGEON EVACUATED A SMALL EFFUSION AND DEBRIDED PERIARTICULAR SYNOVITIS. THE TIBIAL TRAY WAS GROSSLY LOOSE AND EASILY REMOVED. THE SURGEON EXCISED CYSTIC LESION FROM THE UNDERLYING TIBIAL BONE. THE FEMORAL COMPONENT WAS WELL FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL FIXED AND RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOE: (B)(6) 2014. (MUA, NO REVISION, CAPTURED IN (B)(4)). DOR: (B)(6) 2020. LEFT KNEE.

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

  MAUDE report 10785959 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 06 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. IT WAS NOTED THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS AND PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. ATTUNE KNEE COMPONENTS, AND SMARTSET CEMENT X 2 WERE IMPLANTED IN THE PROCEDURE. ON (B)(6) 2014, THE PATIENT UNDERWENT A LEFT KNEE REVISION. THERE WERE NO OPERATIVE NOTES PROVIDED WITH THE MEDICAL RECORDS. DOI: (B)(6) 2014. DOR: (B)(6) 2014 (LT KNEE).

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

  MAUDE report 10778971 ↗
• InjuryOct 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2015 FOR THE PATIENT¿S RIGHT KNEE JOINT VIA TKA. THE REVISION SURGERY WHICH WAS SCHEDULED ON (B)(6) 2020 WAS PERFORMED ON SCHEDULE DUE TO POOR STABILITY. THE SURGEON PLANS TO REPLACE THE TIBIAL INSERT AS THE FIRST CHOICE. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON REPLACED THE TIBIAL INSERT. HE COMMENTED THAT THE TIBIAL INSERT MIGHT HAVE NOT BEEN LOCKED.

  Patient problems: No Code Available

  MAUDE report 10669752 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO UNSPECIFIED DERANGEMENT OF THE LEFT KNEE, LIGAMENTOUS LAXITY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: No Code Available

  MAUDE report 10393168 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED LEFT PRIMARY ATTUNE TKA TO TREAT PAIN SECONDARY TO DEGENERATIVE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND COMPETITOR CEMENT X 2 WAS UTILIZED. INTRAOPERATIVELY, THE SURGEON NOTES THERE WAS EXTENSIVE DEGENERATION OF THE LATERAL COMPARTMENT AND PATELLOFEMORAL JOINT AS WELL AS GRADE II AND GRADE III CHANGES TO THE MEDIAL SIDE. THE NATURAL FEMUR AND TIBIA WERE IN VALGUS. THERE WAS EXTENSIVE BONE LOSS ON THE LATERAL FACET OF THE NATURAL PATELLA. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. CLINIC NOTE DATED (B)(6) 2018 INDICATES THE PATIENT RECEIVED A RADIOGRAPHIC AND PHYSICAL EXAM OF THE LEFT KNEE DUE TO KNEE PAIN. THE PHYSICAL EXAM CONFIRMED PAIN DURING PASSIVE ROM. THE RADIOGRAPHIC STUDY SUGGESTED LOOSENING OF THE TIBIAL TRAY. THE SURGEON RECOMMENDED REVISION OF THE TRAY DURING OFFICE VISIT DATED (B)(6) 2018. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PERSISTENT PAIN SECONDARY TO LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DISCOVERED THAT THE CEMENT DID NOT APPEAR TO BE RIGID AND DID NOT ADHERE TO THE BONE NOR THE TIBIAL TRAY. THE CEMENT TO BONE INTERFACE HAD A SOFT REACTIVE FIBROUS TISSUE THAT WAS DEBRIDED. THE TIBIAL TRAY HAD S

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

  MAUDE report 10134567 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS AN INFECTION.

  Patient problems: Fever; Necrosis; Pain; Unspecified Infection

  MAUDE report 9607261 ↗