ATTUNE 1516-30-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295047995), received between Nov 6, 2017 and Jul 25, 2025 — classified as 21 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED DUE TO STIFFNESS IN THE JOINT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 22611387 ↗
• InjuryJun 21, 2024Adverse 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 PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 19587317 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. REMOVED FEMUR, TIBIA, INSERT, PATELLA AND CEMENT. NO SURGICAL DELAY. NO BROKEN INSTRUMENTS. NO ADVERSE EFFECTS. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : LEFT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 19483360 ↗
• InjuryJan 31, 2023Naturally Worn; Naturally Worn

  PATIENT HAD PRIMARY KNEE REPLACEMENT ON (B)(6) 2018. KNEE PERFORMING WELL INITIALLY BUT PATIENT STARTED EXPERIENCING PAIN IN LAST 6 MONTHS. X-RAYS & BONE SCAN SHOWED TIBIAL LOOSENING. TIBIA & INSERT REMOVED ON (B)(6) 2023 AND REPLACED WITH REVISION TIBIA WITH SLEEVE, STEM & NEW INSERT PLUS PATELLA RESURFACING. PRIMARY TIBIAL IMPLANT WAS OBVIOUSLY LOOSE ON EXAMINING KNEE ONCE JOINT OPENED. CAME OUT EASILY. CEMENT ADHERED TO BONE BUT NOT IMPLANT. INSERT SHOWED SOME SCRATCHING/PITTING ON ARTICULATION SURFACE. PATIENT REQUIRED REVISION SURGERY FOR TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: Pain

  MAUDE report 16273134 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD FALLEN A COUPLE OF TIMES AND THE PATIENT BECAME TIGHT IN FLEXION. THE SIZE 7 6 MM POLY WAS REMOVED AND THE JOINT WAS DEBRIDED. A SIZE 5 POLY INSERT WAS TRIALED AND IT WAS DETERMINED THAT THE 6 MM WAS A BETTER SIZE FOR THE PATIENT. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall; Muscular Rigidity

  MAUDE report 16183620 ↗
• InjuryNov 17, 2022Naturally Worn; Naturally Worn

  REVISION OF TOTAL KNEE REPLACEMENT FOR PAIN AND RESTRICTED MOVEMENT. ONLY POLY WAS EXCHANGED AS IT WAS DAMAGED DURING REMOVAL. MINIMAL WEAR ON ARTICULAR SURFACES, NIL SIGNS OF DAMAGE PRIOR TO REMOVAL. POLY WAS DOWN SIZED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15814351 ↗
• MalfunctionJul 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE RP INSERT WOULD NOT FULLY SEAT IN TRAY AND CEMENT HARDENED ON THE FEMUR. NO LOOSENING AND WITH A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 15043273 ↗
• InjuryMar 10, 2022Unintended Movement; Unintended Movement

  REVISION COMPLETED DUE TO POLY INSERT SPIN OUT RESULTING FROM A FALL. SURGEON FELT THE PATIENT WOULD BENEFIT FROM A POLY EXCHANGE WHERE HE WOULD INCREASE THEIR POLY THICKNESS. HE WENT FROM A SIZE 7, 6MM INSERT TO A SIZE 7, 10MM INSERT. THE ADDED POLY THICKNESS PROVIDED THE APPROPRIATE STABILITY, THE KNEE WAS RANGED, AND THE CLOSING PROCESS BEGAN. DOI: (B)(6), 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 13721598 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON CONDUCTED A POLY EXCHANGE IN ORDER TO TIGHTEN THE KNEE JOINT. DOI: UNKNOWN, DOR: FEB 7, 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13562577 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 11974707 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE TKA TO TREAT POST-TRAUMATIC OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT SUSPECTED TO LOOSENING. UPON ENTERING THE JOINT, SYNOVITIS AND BONY OVERGROWTH WAS DEBRIDED, AND TIGHT FLEXION IDENTIFIED. THE FEMORAL COMPONENT WAS LOOSE AT THE CEMENT TO BONE INTERFACE AND REVISED. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. PATELLA WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR REVISION COMPONENTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Synovitis

  MAUDE report 11659626 ↗
• 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 DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION DUE TO TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE REMOVAL OF ADHESIONS. THE TIBIAL INSERT AND TRAY WERE REVISED. THE PATELLAR AND FEMORAL COMPONENTS WERE RETAINED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2016, DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 11374642 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. IT WAS FOUND THAT THE PCL NEEDED TO BE RELEASED AND A PIECE OF BONE BEHIND THE FEMORAL POSTERIOR CONDYLE ADDED TO THE INSTABILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10857515 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 30 MAR 2020 WERE REVIEWED. ON (B)(6) 2016, THE PATIENT UNDERWENT A COMPUTER-ASSISTED RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, PAIN AND DISCOMFORT. DEPUY COMPONENTS AND DEPUY CEMENT X2 WERE UTILIZED DURING THE PRIMARY SURGERY ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS PAIN, DIFFICULTY WALKING, STIFFNESS MS PAIN WITH ARTHROFIBROSIS. THE PATELLA WAS FOUND TO BE IN GOOD POSITION AND NOT REVISED. THE FEMORAL AND INSERT COMPONENTS WERE REMOVED WITH NO ALLEGATION OF DEFICIENCY. THE TIBIAL COMPONENT HAD NO CEMENT ADHERED TO THE BASE PLATE. COMPETITOR PRODUCTS WERE THEN IMPLANTED WITH UNKNOWN CEMENT. NO COMPLICATIONS NOTED. DOI: (B)(6) 2016. DOR: (B)(6) 2019; (RIGHT KNEE).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Muscular Rigidity; No Code Available; Pain

  MAUDE report 9979029 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS FLEXION CONTRACTURE AND INSTABILITY. SURGEON REMOVED SCAR TISSUE AND REPLACED THE POLYETHYLENE BEARING WITH A THICKER INSERT. HE REMOVED A 6 MM AND IMPLANTED AN 8 MM. CRUCIATE RETAINING ROTATING PLATFORM BEARING. DOI: (B)(6) 2019. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9595898 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY OF THE MEDIAL COLLATERAL LIGAMENT AFTER FALLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED DEVICE AND NOT RELATED TO PROCEDURE. DOI: (B)(6) 2017; DOE: (B)(6) 2019; (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9383197 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION OF HIS RIGHT ATTUNE TOTAL KNEE REPLACEMENT, TO ADDRESS PAIN. NO EVIDENCE OF INFECTION IDENTIFIED. REVISION NOTE INDICATED THAT SURGEON REMOVED THE TIBIA COMPONENT WITH TWO SIMPLE TAPS, AND HE NOTED THAT THERE WAS NO ADHERENT BONE CEMENT ON THE TIBIA COMPONENT. THE TIBIA CEMENT MANTLE, ON THE OTHER HAND, WAS WELL-FIXED TO THE TIBIA BONE. THE FEMUR COMPONENT WAS ALSO WELL-FIXED. TIBIA, FEMUR, AND INSERT COMPONENTS WERE REVISED; PATELLA COMPONENT WAS RETAINED. DOI: (B)(6) 2014; DOR: (B)(6) 2015; (RIGHT KNEE).

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

  MAUDE report 9378854 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 11 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR BONE CEMENT. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE STIFFNESS, PAIN, CONTRACTURE, AND MECHANICAL COMPLICATION. THE SURGEON INDICATED THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED. HE DID NOT OFFER CONDITION OF THE COMPONENTS NOR THE NATURE OF THE MECHANICAL COMPLICATION, BOTH COMPONENTS WERE REVISED. THE SURGEON REPORTED THE PATELLA WAS STABLE AND NOT REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND UNKNOWN CEMENT. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015, DOR: (B)(6) 2017 (LT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9282310 ↗
• MalfunctionSep 11, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING TRIALING OF THE REVISION KNEE WITH THE REAL TIBIAL TRAY CEMENTED INTO PLACE IT WAS DEEMED A 6 MM CR RP INSERT TRIAL OFFERED DESIRED STABILITY. AT THIS POINT A REAL SZ 7 6 MM CR RP ATTUNE INSERT WAS OPENED AND IMPLANTED. IT WAS IMMEDIATELY CLEAR THE REAL INSERT TENSION WAS NOT THE SAME AS THE PREVIOUS TRIAL OF THE SAME SIZE. THE SURGEON REMOVED THE REAL IMPLANT AND TRIALED THE 6 MM CONSTRUCT AGAIN AND WAS AGAIN SATISFIED WITH THE WAY THE TRIAL FELT. THE REAL IMPLANT WAS AGAIN INSERTED AND FOUND TO BE LESS STABLE THAN THE TRIAL. AT THIS POINT A DECISION WAS MADE TO OPEN A REAL 7 MM INSERT AND SEE HOW THAT FELT AND IT OFFERED THE SAME STABILITY AS THE 6 MM TRIAL. PLEASE NOTE, THIS IS A SECOND INDEPENDENT DEVICE REPORT FOR THE SAME PATIENT.

  Patient problems: Not Applicable

  MAUDE report 8989981 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WAS REMOVED. DOI: UNK. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8745511 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, ON (B)(6) 2019, THE PATIENT PRESENTED FOR AN EVALUATION OF THE LEFT KNEE DUE TO INSTABILITY, PAIN, AND RECURRENT FALLS. THE SURGEON NOTED A PLAN TO REVISE THE FEMORAL COMPONENT AS WELL AS THE TIBIAL INSERT, AND HOPEFULLY RETAIN THE TIBIAL COMPONENT. HOWEVER, THE REVISION OPERATIVE NOTES WERE NOT AVAILABLE AT THE TIME OF REVIEW. THE STICKER SHEET FOR THE REVISION OPERATION ON (B)(6) 2019 WAS REVIEWED AND ONLY SHOWED A TIBIAL INSERT WAS EXCHANGED.

  Patient problems: No Code Available; Pain

  MAUDE report 8692872 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2017. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7262881 ↗
• InjuryNov 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7003060 ↗