ATTUNE 1516-30-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295047636), received between Mar 1, 2018 and Jan 9, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Unintended Movement” (4 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.

• InjuryJan 9, 2026Fracture

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT, THE IMPLANTS WAS ALREADY IMPLANTED IN THE PATIENT WHEN THIS OCCURRED. FURTHERMORE, EXPIRED DATE ARE ONLY VISIBLE ON THE PACK.

  Patient problems: Insufficient Information

  MAUDE report 24018957 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE : UNKNOWN.

  Patient problems: Pain

  MAUDE report 18939852 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED 4 WEEKS POST-OP DUE TO INFECTION, WASHOUT + POLY EXCHANGE. INFECTION FOLLOWING CAT BITE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. UNK KNEE. IF OTHER, DESCRIBE:I INFECTION FOLLOWING CAT BITE POST OP. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. FACILITY NAME OF ORIGINAL IMPLANT: (B)(6) HOSPITAL . WAS DEVICE EXPLANTED? FALSE. HARDWARE/EXPLANT REMOVAL DUE TO: WASHOUT + POLY EXCHANGE. DID PATIENT REQUIRE REVISION SURGERY? TRUE. IF YES, DATE OF REVISION SURGERY. REASON FOR REVISION SURGERY: INFECTION POST CAT BITE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.

  Patient problems: Unspecified Infection

  MAUDE report 18478370 ↗
• InjuryDec 1, 2023Unintended Movement; Unintended Movement

  ON (B)(6) 2021, THE PATIENT UNDERGOES A RIGHT TOTAL KNEE ARTHROPLASTY INCLUDING PATELLA RESURFACING AND USE OF DEPUY SYNTHES BONE CEMENT. THERE ARE NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2021, THE PATIENT WAS REVISED DUE TO SYMPTOMS OF PAIN, BURNING, AND INSTABILITY WITH XRAY SUGGESTION THAT THERE WAS LIKELY A POLY SPINOUT. INTRAOPERATIVE FINDINGS WERE THAT THE EXTENSOR MECHANISM WAS EXTREMELY POOR AT THE QUADRICEPS TENDON DUE TO THE PATIENT RECENTLY BEING OPERATED ON. THE POLY WAS CONFIRMED TO HAVE SPUN OUT. ALL COMPONENTS WERE REMOVED WITH EXCEPTION OF THE PATELLA AND AN SROM HINGED CONSTRUCT WAS PLACED. THE SROM HINGE WAS SELECTED AS THE PATIENT WOULD HAVE REQUIRED TOO LARGE OF A POLY INSERT TO CAUSE PATELLA BAJA. THERE WERE NO FURTHER COMPLICATIONS NOTED AFTER THE REVISION. DOI: (B)(6), RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18250323 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN ATTUNE. RIGHT SIDE. PRIMARY WAS DONE IN 2018. THEY HAD A DEBRIDEMENT AND MUA IN 2019. REVISION OF THE FEMORAL COMPONENT AND INSERT IN 2020. THEY HAVE HAD ONGOING ISSUES SINCE FIRST SURGERY IN 2018. THIS REVISION WAS DUE TO STIFFNESS AND PAIN.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18013169 ↗
• InjuryAug 25, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ATTUNE CR RP INSERT SPUN OUT. IT WAS UNKNOWN ABOUT SURGICAL DELAY AND THERE WAS NO LOOSENING. DOI: MAY 23, 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17623452 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INSTABILITY, WENT UP IN POLY THICKNESS FROM 6MM TO 10MM. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16618357 ↗
• InjuryApr 19, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TKA SURGERY FOR OA OF RIGHT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, SPIN-OUT WAS FOUND. THE SURGEON COMMENTED THAT THE CAUSE OF SPIN-OUT WAS UNKNOWN. IT HAS BEEN CONFIRMED BY THE SURGEON BY X-RAY THAT THERE ARE NO BROKEN PIECES IN THE BODY. ON (B)(6) 2022, THE REVISION SURGERY WILL BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 14143437 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS TOTAL KNEE REVISION DUE TO SOFT TISSUE IMBALANCE AND VARUS TIBIAL ALIGNMENT. ALL PARTS WERE REMOVED AND REPLACED WITH AN ATTUNE CRS REVISION CONSTRUCT. THE NONCEMENTED FEMUR AND TIBIAL WERE WELL FIXED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13757737 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR AN ATTUNE TKR. NO COMPONENTS WERE LOOSE. THE REASON FOR THE REVISION WAS BECAUSE THE PATIENT HAD A VERY STIFF KNEE. THE PATIENT WAS UNABLE TO BEND PAST 85 DEGREES OR FULLY STRAIGHTEN. THE 6MM POLY LINER WAS REMOVED AND SOFT TISSUE WAS DEBRIDED. A 5MM POLY WAS THEN IMPLANTED. THE KNEE COULD THEN COME OUT STRAIGHT AND WAS ABLE TO BEND SUFFICIENTLY. DOI: (B)(6) 2021. DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Scar Tissue

  MAUDE report 13392490 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS CAUSALLY RELATED TO DEVICE AND IS CAUSALLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA. PRE-MANIPULATION (IN DEGREES): EXTENSION: 5; HYPEREXTENSION FLEXION: 90. POST-MANIPULATION (IN DEGREES): EXTENSION: 0; HYPEREXTENSION FLEXION: 130.

  Patient problems: Adhesion(s)

  MAUDE report 13307603 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LEFT ATTUNE TKR ON (B)(6) 2018. PATIENT SUBSEQUENTLY FELL ON (B)(6) 2018 AND SUFFERED A LEFT DISTAL FEMORAL PERIPROSTHETIC FRACTURE. THIS WAS TREATED WITH DISTAL FEMORAL PLATING. PATIENT HAD SWELLING, FEVERS, ERYTHEMA AND PAIN ON (B)(6) 2018, WHICH WAS TREATED WITH ANTIBIOTICS AND SETTLED. NOW PRESENTING BACK TO SURGEON WITH A 6 WEEK HISTORY OF PAIN, SWELLING, HYPEREXTENSION AND CELLULITIS LEFT KNEE. PROCEDURE TODAY, ARTHROTOMY AND EXPLORATION LEFT TOTAL KNEE REPLACEMENT. SURGEON EXPLORED THE PROSTHESIS BONE INTERFACE AND WAS SATISFIED THAT THE FEMORAL AND TIBIAL COMPONENTS APPEARED WELL FIXED STILL AND NOT LOOSE. HE EXAMINED THE DISTAL FEMORAL PLATES AND REMOVED ONE SCREW WHICH WAS PROTRUDING. HE STATED THE CONSTRUCT WAS STILL WELL FIXED. HE REMOVED THE EXISTING 6MM POLY AND PERFORMED A TRIAL WITH AN 8MM POLY. HE WAS SATISFIED WITH THE KNEE STABILITY AND ROM. PROCEEDED TO INSERT AN 8MM POLY AND RESURFACE THE PATIENTS PATELLA. INFECTION SUSPECTED, MULTIPLE SPECIMENS SENT, BUT NOT CONFIRMED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Inflammation; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 12959899 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR SAID THE PATIENT WAS EXPERIENCING SOME ANTERIOR PAIN AND MAY HAVE A FLEXION CONTRACTURE. HE THEN PREPPED THE NATIVE PATELLA AND CONVERTED THE KNEE FROM A CS TO A PS KNEE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Joint Contracture; Pain

  MAUDE report 11058258 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFF RIGHT TKA: ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE, EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: CLOSED KNEE MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 10929496 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS NOTED A THIRD PROCEDURE WAS PERFORMED ON THE RIGHT KNEE SEVERAL WEEKS AFTER THE PROCEDURE ON (B)(6) 2017. THE PROCEDURE WAS COMPLETED FOR ASPIRATION OF FLUID ON THE RIGHT KNEE. THERE IS NO EVIDENCE NOR ALLEGATION THAT ANY PRODUCTS WERE REVISED DURING THE PROCEDURE. THE PROCEDURE NOTES WERE NOT AVAILABLE AT THE TIME OF REVIEW. DOI: (B)(6) 2017. DOE 1: (B)(6) 2017; ((B)(4)). DOE 2: UNKNOWN, RIGHT KNEE.

  Patient problems: Edema; No Code Available

  MAUDE report 10493882 ↗
• InjuryJun 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT RECEIVED LEFT PRIMARY ATTUNE TKA TO TREAT KNEE PAIN SECONDARY TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVE A LEFT KNEE REVISION DUE INSTABILITY SECONDARY TO LOOSENING OF THE TIBIAL INSERT. UPON ENTERING THE JOINT, THE INSERT WAS NOTED TO BE DISLOCATED AND EXTERNALLY ROTATED ON THE MEDIAL SIDE AND NO LONGER UNDER THE FEMORAL COMPONENT CAUSING A LARGE LAXITY ON THE FEMORAL SIDE. THE FEMORAL COMPONENT, TIBIAL TRAY, AND PATELLA WERE WELL-FIXED AND RETAINED. THE MANUFACTURER OF THE REVISED TIBIAL INSERT WAS NOT PROVIDED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10134280 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9811547 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSERT WAS REPLACED DURING AN IRRIGATION AND DEBRIDEMENT FOR INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9643566 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9545181 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF ALL COMPONENTS. DECREASED ACTIVITY, AND PAIN. THE SURGEON INDICATED AFTER SEVERAL IMPACTIONS WITH A BONE TAMP MALLET, THE TIBIAL BASEPLATE DISLODGED FROM THE CEMENT MANTLE AND WAS REMOVED. HE REPORTED THE FEMORAL COMPONENT CAME OUT WITH SEVERAL IMPACTIONS OF THE BONE TAMP AND MALLET AND WAS RELATIVELY EASY TO REMOVE. THE SURGEON INDICATED THE PATELLA WAS GROSSLY LOOSE AND REMOVED FROM ITS CEMENT BED WITH LITTLE EFFORT USING A TONSIL. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2016; (RT KNEE).

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

  MAUDE report 9503668 ↗
• InjurySep 13, 2019Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  MEDICAL RECORDS RECEIVED (B)(6) 2019 AND WERE REVIEWED (B)(6) 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHROSIS, AND PAIN. THE PATIENT WAS TRANSFERRED TO RECOVERY IN GOOD CONDITION. ALL ATTUNE COMPONENTS, AND TWO SMARTSET CEMENTS WERE UTILIZED IN THE PROCEDURE. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY OF THE TIBIAL INSERT, EPISODES OF SUBLUXATION, AND PAIN. THE SURGEON NOTED THE TIBIAL INSERT WAS SPINNING OUT, CAUSING THE KNEE TO SUBLUX, AND REPLACED IT WITH A DIFFERENT SIZED INSERT. THERE WERE NO COMPLAINTS AGAINST ANY OF THE COMPONENTS. ALL ATTUNE COMPONENTS WERE UTILIZED FOR THIS PROCEDURE. DOI: (B)(6) 2016; DOR: (B)(6) 2016 (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9046601 ↗
• InjuryJun 15, 2018Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated

  RECEIVED MEDICAL RECORDS ON 05/18/2018. PATIENT HAS BILATERAL ATTUNE TOTAL KNEES. RIGHT KNEE WAS REVISED TO ADDRESS INSTABILITY AND SUSPECTED TIBIAL COMPONENT LOOSENING. INTRAOPERATIVELY, THE REVISING SURGEON STATED, "IT WAS NOTED THAT THE MEDIAL SIDE OF THE KNEE WAS QUITE LAX AND THERE WAS NO STABILITY ON THAT SIDE. BECAUSE OF THIS, THE POLYETHYLENE INSERT WAS COMING LOOSE FROM THE TIBIAL COMPONENT AND WAS NOT TOTALLY LOOSE, BUT WAS SHIFTING AND THE KNEE WAS TOTALLY UNSTABLE." THE SURGEON DETERMINED THAT THE TIBIAL BASE PLATE COMPONENT WAS NOT LOOSE, NOR WAS THE FEMUR COMPONENT. A THICKER POLYETHYLENE INSERT WAS IMPLANTED. THE PATIENT WAS PLACED IN A HINGED KNEE BRACE POST-OPERATIVELY. FEMUR, TIBIAL TRAY, AND PATELLA COMPONENTS WERE LEFT UNREVISED. POST-OP DIAGNOSIS WAS MEDIAL COLLATERAL LIGAMENT TEAR AND LOOSE TIBIAL INSERT COMPONENT--THERE WAS NO SUGGESTION THAT PRODUCTS CONTRIBUTED TO THE LIGAMENT INJURY. DOI: (B)(6) 2016; DOR: (B)(6) 2018; (RIGHT KNEE).

  Patient problems: No Code Available; Not Applicable; Tissue Damage

  MAUDE report 7604650 ↗
• InjuryMar 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND FUSION, NO IMPLANTS WERE LOOSENED. INSERT WAS CHANGED. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7305706 ↗