ATTUNE 1516-20-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295045533), received between Jan 11, 2018 and Sep 23, 2026 — classified as 27 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Device Dislodged or Dislocated

  Patient problems: Pain

  MAUDE report 50873834 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patients presents with poor motion and instability post primary TKA. All components were found to be well fixed and well aligned however there was significant patella baja noted. It was unknown if this was present at the time of the primary knee or developed due to lack of motion. No allegation was made against any component. No patient harm nor delay was noted. Cement was hand mixed by surgeon in an open bowl. No other information about storage, time or information was available.Cement Manufacturer was DePuy Synthes.Affected Side: Right Knee.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 50301615 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE PAIN OF LEFT KNEE - PRIMARY CHRONIC PAIN OF RIGHT KNEE, OSTEOARTHRITIS OF RIGHT KNEE, ACUTE PAIN OF LEFT KNEE DEVICE AND PROCEDURE (RELATEDNESS) DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 13 OCT 2022 DATE OF IMPLANT: (B)(6) 2017 DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT TREATMENT/IMPACT: INJECTED MEDICATION: YES.

  Patient problems: Pain

  MAUDE report 24459510 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION OF KNEE; REVISED THE POLY FOR INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 23304438 ↗
• MalfunctionFeb 12, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  DURING A TOTAL KNEE REPLACEMENT IMPLANTS WERE BEING CEMENTED. WHILE WAITING FOR THE CEMENT TO DRY THE SURGEON NOTICED A DEFECT ON THE POLY SURFACE. THERE IS A GOUGE MARK AND SCRATCHES ON THE SURFACE. IT IS NOT BELIEVED TO BE CAUSED BY INSERTION. ANOTHER POLY WAS OPENED AND THE SURGERY WAS COMPLETED BUT DELAYED 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366414 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INSTABILITY AND BONE FRACTURE.

  Patient problems: Joint Laxity

  MAUDE report 18963107 ↗
• InjuryNov 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS OPERATED ON FOR KNEE REPLACEMENT (B)(6) 2023. ATTUNE CR FEMUR SZ 4 LEFT, TIBIA SZ 4, INSERT SZ 4, 6 MM. PATIENT LUXATES THE KNEE JOINT SEVERAL TIMES, AND IS REPAIRED SEVERAL TIMES DURING A TIME FRAME OF ONE WEEK. TODAY, (B)(6) 2023 REVISED BECAUSE THE SITUATION FOR THE PATIENT HAS BECOME UNTENABLE. THE INSERT WAS LOOSE FROM THE LOCKING MECHANISM ON TIBIA COMPONENT WHEN OPENING THE KNEE JOINT. REPLACED THE PLASTIC INSERT FROM 6 MM TO 10 MM, AND THE PATIENT IS IN A FULL LEG STABILIZED WITH CEMENT AFTER THE OPERATION.

  Patient problems: Joint Dislocation

  MAUDE report 18047730 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL ON THE HOSPITAL FLOOR AFTER SURGERY WHILE IN THE RESTROOM. SURGEON TRIED A 6MM POLY BUT HAD TO GO UP TO A 12MM POLY FROM THE PATIENT FALLING AND INJURING THE TISSUE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 17350612 ↗
• MalfunctionJun 21, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AND SUBSIDENCE AT CEMENT TO IMPLANT INTERFACE . THE PATIENT'S PRIMARY ATTUNE FIXED BEARING TIBIAL BASE AND CRUCIATE RETAINING FIXED BEARING INSERT WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. THERE WAS NO CEMENT ATTACHED TO THE UNDERSIDE OF THE TIBIAL BASE, WHICH WOULD SUGGEST THAT THERE WAS A FLAW IN THE DESIGN OF THE TIBIAL BASE ACCORDING TO THE SURGEON DEPUY SMARTSET GMV BONE CEMENT WAS USE DURING THE PRIMARY PROCEDURE. THE LOT NUMBERS FOR THE CEMENT USED IS NOT AVAILABLE, SINCE IT WAS ORDERED DIRECTLY FROM DEPUY BY THE HOSPITAL. DOI: (B)(6) 2017, DOR: (B)(6) 2023, AFFECTED SIDE : LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17169623 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION LEFT TOTAL KNEE ARTHROPLASTY WITH EXCHANGE OF POLYETHYLENE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE).

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 17163385 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF PAIN, POOR MOTION AND INSTABILITY. A THICKER INSERT WAS PLACED AND PATELLA WAS REPLACE AS SURGEON THOUGHT IT WAS TOO THICK. NO PATIENT HARM OCCURRED. NO MALALIGNMENT, UNDERSIZING, OR ELEVATION OF JOINT LINE WAS NOTED. MECHANICAL ALIGNMENT WOULD HAVE BEEN UTILIZED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 16672835 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THE FOLLOWING: THE DEBRIDEMENT TREATMENT WAS PERFORMED AND THE INSERT IN QUESTION WAS REPLACED WITH 7MM ON (B)(6) 2023. ON (B)(6) 2023, THE FLAP SURGERY WAS PLANNED TO PERFORM, BUT THE SURGEON CHOSE THE DEBRIDEMENT TREATMENT DUE TO THE SUSPICION OF RE-INFECTION. INSERT WAS REPLACED TO 6MM THIS TIME. SKIN FLAP SURGERY WILL BE PERFORMED IN THE FUTURE. REGARDING THE CAUSE OF THE INFECTION, THE SURGEON OPINED THAT IT WAS A SUPERFICIAL INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16451591 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER RIGHT KNEE REPLACED ON (B)(6) 2022. SHE THEN FELL AND BUSTED OPEN HER INCISION SITE. DURING THIS PROCEDURE, THE SURGEON WASHED OUT THE PATIENT'S KNEE (JOINT) AND REPLACED HER PRIMARY ATTUNE TIBIAL INSERT WITH A STERILE REPLACEMENT INSERT OF THE SAME SIZE AND THICKNESS. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15932853 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15615144 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND DEHISCENCE OF WOUND NEEDED WASHOUT AND POLY SWAP. DOI: (B)(6) 2022. DOR: JUL 8, 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15111986 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT IN FLEXION. IT HAD DROPPED DOWN ONE POLY SIZE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 14852375 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD FALLEN AND SPRAINED HER ANKLE AND LANDED ON HER KNEE WHILE DOING IT. IMPLANTS WERE ALL WELL FIXED. PATIENTS SOFT TISSUES WERE LOOSE. THE DOCTOR INCREASED POLY FROM 6MM TO 10MM FOR THE STABILITY AND ROM. POSTS ON THE ARTICULAR SURFACE BROKE OFF. DOI: (B)(6) 2018; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 13900574 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE ARTICLE ENTITLED, ¿DOES CIRCUMFERENTIAL PATELLAR DENERVATION RESULT IN DECREASED KNEE PAIN AND IMPROVED PATIENT-REPORTED OUTCOMES IN PATIENTS UNDERGOING NON-RESURFACED, SIMULTANEOUS BILATERAL TKA?¿ BY NICOLAAS C. BUDHIPARAMA MD, ET AL, PUBLISHED BY CLINICAL ORTHOPAEDICS RELATED RESEARCH (2020), VOL. 428, PP. 2020-2033 WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF PATELLAR DENERVATION IN 78 PATIENTS RECEIVING BILATERAL ATTUNE PRIMARY TKAS WITHOUT PATELLAR RESURFACING BETWEEN FEB 2015 AND OCTOBER 2016. IN ALL BILATERAL PROCEDURES, THE PATELLAR DENERVATION VIA CAUTERIZATION OF THE PATELLAR RIM WAS ALWAYS PERFORMED ON THE RIGHT KNEE. THE AUTHORS CONCLUDED THAT THERE WAS NO CLINICAL DIFFERENCE BETWEEN THE CAUTERIZED AND NON-CAUTERIZED KNEES. DEPUY COMPONENTS: ATTUNE FEMORAL COMPONENT, TIBIAL TRAY, AND TIBIAL INSERT. THERE WAS NO PATELLAR RESURFACING AND THE TYPE OF CEMENT USED IS UNKNOWN. RESULTS: 3 REPORTS OF DEEP VEIN THROMBI AT 6 MONTHS POST INDEX TKA. THE AUTHORS NOTE THAT ALL WERE TREATED SUCCESSFULLY, BUT THE INTERVENTION THAT WAS PROVIDED WAS NOT SPECIFIED. CAPTURED IN THIS COMPLAINT: 3 BILATERAL ATTUNE TKAS FOR DEEP VEIN THROMBUS (3 RIGHT KNE

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 11186882 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A TKR ON (B)(6) 2020. PRESENTED AT CASUALTY LAST NIGHT WITH AN OOZING WOUND. UNDERWENT A DEBRIDEMENT, WASH OUT AND INSERT EXCHANGE THIS MORNING FOR INFECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11132608 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2017: THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. ATTUNE IMPLANTS WERE UTILIZED WITH DEPUY CEMENT X1. PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. (B)(6) 2019: THE PATIENT UNDERWENT LEFT KNEE REVISION DUE TO PERSISTENT PAIN, SWELLING, INSTABILITY AND SUSPECTED LOOSENING. SURGEON INDICATES THE CASE COMPLEXITY IS HIGH DUE TO ¿SEVERE LIGAMENTOUS LAXITY FROM THE FAILED KNEE ARTHROPLASTY.¿ THE INTRAOPERATIVE NOTES DO NOT CLEARLY CONFIRM LOOSENING BUT NOTES THE COMPONENTS WERE REMOVED WITHOUT COMPLICATIONS OR BONE DAMAGE. INTRAOPERATIVELY, SURGEON REVISES ALL COMPONENTS (PATELLA, FEMORAL, INSERT AND TIBIAL) AND REPLACED WITH NON-DEPUY REVISION KNEE SYSTEM AND WITH NON-DEPUY CEMENT. DOI: (B)(6) 2017; DOR: (B)(6) 2019 (PATELLA, FEMORAL, TIBIAL AND INSERT).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9554653 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP WAS DONE. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9376075 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, ADHESIONS, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA COMPONENT WAS NOT REVISED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014. DOR:(B)(6) 2018; RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9278895 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PAIN, DISCOMFORT, STIFFNESS, ADHESIONS, DECREASED RANGE OF MOTION, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA COMPONENT WAS NOT REVISED. UNKNOWN CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Adhesion(s); Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9273498 ↗
• InjuryOct 28, 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 03 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO PRIMARY DEGENERATIVE ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR CEMENT. ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY. THE SURGEON INDICATED THE TIBIAL COMPONENT AND FEMORAL COMPONENTS WERE NOT LOOSE, THOUGH THEY WERE UNSTABLE. THE SURGEON DID NOT INDICATE FURTHER REGARDING THE INSTABILITY, AND BOTH THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED. HE NOTED THE PATELLA WAS TRACKING NICELY, AND WAS NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016, DOR: (B)(6) 2017 (RT KNEE).

  Patient problems: No Code Available

  MAUDE report 9245892 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS MID FLEXION INSTABILITY. REVISED TO AN ATTUNE REVISION KNEE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9136179 ↗