ATTUNE 1516-30-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295047872), received between Sep 13, 2018 and Aug 28, 2025 — classified as 34 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN AND A BIT OF HYPEREXTENSION. SURGEON UPSIZED POLY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22911955 ↗
• InjuryMar 17, 2025Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE ADVERSE CONSEQUENCE OF THE SPIN OUT WAS THE PATIENT HAVING A REVISION. NO OTHER ALLEGATIONS.

  Patient problems: Insufficient Information

  MAUDE report 21620251 ↗
• InjuryJan 17, 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 STIFFNESS. FEMUR TRAY AND POLY WERE ALL REVISED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 21180847 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, PATIENT REPORTEDLY RECEIVED A LEFT TOTAL KNEE REVISION TO ADDRESS PAIN, FLEXION INSTABILITY, AND ASEPTIC LOOSENING OF THE TIBIAL BASEPLATE. SURGEON IDENTIFIED THAT ALTHOUGH THE FEMUR WAS WELL-FIXED, THE FLEXION INSTABILITY REQUIRED REVISION OF THE FEMUR AND TIBIA. THE TIBIAL TRAY WAS LOOSE--INTERFACE UNSPECIFIED. THE PATELLA WAS FOUND TO BE WELL-FIXED AND WAS RETAINED. FEMUR WAS REPLACED WITH DEPUY ATTUNE REVISION FEMUR SIZE 6, A 30MM SLEEVE, AND 4MM DISTAL AND POSTERIOR AUGMENTS, AND A 14 X 60 FEMORAL STEM. THE TIBIAL TRAY WAS REPLACED WITH AN ATTUNE REVISION TIBIAL TRAY SIZE 6, A 37MM SLEEVE, AND 14 X 60 TIBIAL STEM. THERE WERE NO COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20664275 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH WASHOUT OF LEFT KNEE. NO FURTHER INFORMATION IS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20621751 ↗
• InjuryOct 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMS THAT DEPUY CEMENT WAS NOT USED DURING PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 20555993 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 5 JUN 2024. ON (B)(6) 2017, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS. DEPUY COMPONENTS WERE PLACED DURING THIS PROCEDURE, INCLUDING DEPUY CEMENT AND PATELLA. ON (B)(6) 2023, THE PATIENT HAD A RIGHT TOTAL KNEE REVISION TO ADDRESS ASEPTIC LOOSENING OF THE RIGHT TOTAL KNEE AND FEMORAL OSTEOLYSIS. PRIOR TO SURGERY, THE PATIENT WAS REPORTED TO HAVE HAD PAIN, DECREASE RANGE OF MOTION, STIFFNESS, FIBROSIS, DECLINING FUNCTION. DURING THE PROCEDURE, THE SURGEON REPORTED FINDING OSTEOLYSIS OF THE FEMUR AND NO CEMENT ADHERED TO BACK OF THE TIBIAL TRAY. (LOOSENING) OSTEOPHYTES WERE REMOVED FROM THE PATELLA. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE, INCLUDING COMPETITOR CEMENT. UPDATE AD (B)(6) 2024: UPDATE EVENT DESCRIPTION: ON (B)(6) 2017, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS DEGENERATIVE ARTHRITIS. DEPUY COMPONENTS WERE PLACED DURING THIS PROCEDURE, INCLUDING DEPUY CEMENT AND PATELLA. (B)(6) 2022 MEDICAL RECORDS NOTE RIGHT KNEE PAIN AND DYSFUNCTION AFTER TKA, AS WELL AS LEFT KNEE PAIN (NO IMPLANT) RIGHT KNEE PAIN, SWELLING, DECREASE RANGE OF MOTION, STIFFNESS. PATIENT HAD A PREVIOUS INJECTIO

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

  MAUDE report 19567941 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 16 MAY 2023.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 17097355 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 PATIENT HAS RIGHT KNEE PAIN, GAIT INSTABILITY, JOINT SWELLING, LIMPING, WEAKNESS, AND KNEE GIVING AWAY. SHE WAS TREATED WITH PHYSICAL THERAPY, NSAIDS, ALEVE AND DRY NEEDLING. IT WAS NOTED THE PATIENT HAD RECEIVED LUMBAR EPIDURAL INJECTIONS DUE TO LUMBAR SPONDYLOLISTHESIS, DISC DEGENERATION, AND IDIOPATHIC SCOLLOSIS LUMBAR REGION

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17097000 ↗
• InjuryFeb 27, 2023Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PRIMARY SURGERY WAS DONE WITH DEPUY CEMENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: Osteolysis; Unspecified Tissue Injury

  MAUDE report 16442648 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017: PATIENT RECEIVED A RIGHT KNEE ATTUNE TKA TO TREAT CHONDROMALACIA TYPE II/III AND END-STAGE DJD AFTER FAILED ATTEMPTS TO MANAGE THE SYMPTOMS. THE PATIENT HAD A SKIING ACCIDENT SEVERAL YEARS EARLIER WHERE THE ACL WAS TORN AND HAS REQUIRED INJECTIONS AND ARTHROSCOPIC SURGERIES, WHICH UNSUCCESSFULLY TREATED THE PAIN AND DEGENERATION OF THE KNEE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2018, PATIENT HAD RIGHT KNEE MANIPULATION UNDER ANESTHESIA WITH AN INTRAARTICULAR STEROID INJECTION TO TREAT PAIN, STIFFNESS AND REDUCED ROM SECONDARY TO ARTHROFIBROSIS. DOE: (B)(6) 2018; RIGHT KNEE SECOND COMPLAINT.

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

  MAUDE report 15851635 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE LITIGATION RECORDS RECEIVED. PATIENT WAS REVISED WAS DUE TO PAIN AS A RESULT OF MECHANICAL LOOSENING, UNKNOWN INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 15844286 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS REVISED DUE TO INSTABILITY. NO PREVIOUS REVISION. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15843428 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED WITH I&D AND POLY EXCHANGE DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15793151 ↗
• InjuryOct 12, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE PRIMARY SURGERY FOR OA VIA TKA USING THE ATTUNE CR RP INSERT IN QUESTION WITH CEMENT . THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS INFORMED TO US FROM THE SURGEON ON (B)(6) 2022, THE INSERT SEEMS TO HAVE SPUN OUT. ON (B)(6), THE INSERT WAS REPLACED TO A NEW THICKER INSERT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON¿S OPINION WAS THAT THE PCL HAD CUT DURING REHABILITATION, CAUSING LOOSENING AND CAUSING THE INSERT TO SPIN OUT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15586893 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO TISSUE SCARING THAT MADE THE JOINT TOO TIGHT. THE DOCTOR DOWNSIZED THE POLY'S THICKNESS AND RESURFACED THE PATELLA. DOI- (B)(6) 2021. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 14604584 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUPERFICIAL INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: 28/JUL/2021. DATE OF REVISION: (B)(6) 2021. (LEFT KNEE). TREATMENT: REVISION OF THE TIBIAL INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 14472417 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HYPEREXTENSION FLEXION OF 90 DEGREES. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT HAS A CAUSAL RELATIONSHIP TO DEVICE AND CAUSAL RELATIONSHIP TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2022 (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 13424645 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION OF ALL COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 13366590 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. PATIENT HAD POLY INSERT EXCHANGED. SURGEON INCREASED POLY THICKNESS FROM 6MM TO 8MM INSERT. THERE WAS NO DEFICIENCY NOTED WITH THE PRODUCT AND NO DELAY IN PROCEDURE. LOT NUMBER OF THE EXPLANTED POLY WAS NOT LEGIBLE AND INSERT IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12585588 ↗
• InjuryOct 4, 2021Unintended Movement; Unintended Movement

  REVISION AND EXCHANGE OF POLY BEARING. ATTUNE BEARING WAS UPSIZED TO A THICKER POLY DUE TO A BEARING SPIN OUT. ORIGINAL PRIMARY OP DATE WAS (B)(6) 2021. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12569034 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. PATIENT WAS HAVING PROBLEMS WITH MOBILITY AND UNDERGOING A MANIPULATION UNDER ANESTHESIA. TIBIAL INSERT WAS EXCHANGED WITH THICKER TIBIAL INSERT. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 11616705 ↗
• MalfunctionApr 1, 2021Missing Information; Missing Information

  IT WAS REPORTED THAT THE POLY HAD NO STICKERS OR BOOKLET IN BOX. COULD NOT CONFIRM DATE ON THE OUTSIDE OF THE PACKAGE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605658 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE REVISION. ATTUNE PRIMARY REVISED FOR MID FLEXION INSTABILITY. IMPLANTS WERE ABSOLUTELY SOLID AND NO PROBLEM REGARDING THE IMPLANTS AT ALL.

  Patient problems: Joint Laxity

  MAUDE report 11561528 ↗
• InjuryMar 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION DUE TO FALL. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 11464288 ↗