ATTUNE 1516-20-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295045540), received between Aug 25, 2017 and Jul 22, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD LEFT KNEE REPLACED ON (B)(6) 2026 BY SURGEON. THE PATIENT WAS DOING WELL INITIALLY BUT FELL DOWN ON LEFT KNEE AND RUPTURED THE QUAD. PATIENT WAS SENT TO HOSPITAL WHERE SURGEON DID A THOROUGH I&D WITH A QUAD TENDON REPAIR. THE POLY WAS EXCHANGED WITH A NEW POLY. THE FEMUR, TIBIAL TRAY, AND PATELLA WERE LEFT IN-SITU. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 25903907 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS INFECTED. THE PATIENT UNDERWENT INCISION AND DRAINAGE AND INSERT EXCHANGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23071958 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT KNEE WAS INFECTED. AN INCISION, DRAINAGE AND AN EXCHANGED, ALSO A TIBIAL INSERT WAS PERFORMED DOI (B)(6) 2025, DOR (B)(6) 2025, AFFECTED SIDE - RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23022244 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY FOLLOWING A DISTAL FEMUR FRACTURE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21950014 ↗
• MalfunctionNov 13, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS FOUND THAT THE INSERT COULD NOT BE LOCKED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678269 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR PINS AND NEEDLES L KNEE AND LIMITED ROM. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE) (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Loss of Range of Motion; Paresthesia

  MAUDE report 17488383 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DEHISCENCE DUE TO SUTURE REACTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2015. DATE OF EVENT: (B)(6) 2015. (RIGHT KNEE). TREATMENT: MEDICAL INTERVENTION/ MODIFICATION (UNSPECIFIED).

  Patient problems: Wound Dehiscence

  MAUDE report 15978796 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF EVENT: (B)(6) 2018. RIGHT KNEE. TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 14886714 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SECOND MANIPULATIONS OF KNEE UNDER ANESTHESIA: ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: KNEE MANIPULATION. PRE-MANIPULATION (IN DEGREES): EXTENSION: 15. HYPEREXTENSION FLEXION: 70. POST-MANIPULATION (IN DEGREES): EXTENSION: 0. HYPEREXTENSION FLEXION: 120.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 13266091 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS UNSTABLE. POLY WAS CHANGED TO MAKE IT STABLE AGAIN. DOI: (B)(6) 2017, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12703583 ↗
• InjuryOct 4, 2021Adverse 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 MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA ON (B)(6) 2021.

  Patient problems: Adhesion(s)

  MAUDE report 12573887 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED BECAUSE OF UNHAPPINESS. THE SURGEON TIGHTENED UP THE KNEE BY IMPLANTING A THICKER INSERT. DOI: UNKNOWN- DOR: (B)(6) 2016 (RIGHT KNEE).

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 10950728 ↗
• InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2020. UNKNOWN SIDE OF KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10002481 ↗
• InjuryApr 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE REPLACEMENT TO ADDRESS CHRONIC PAIN AND OSTEOARTHRITIS. PATELLA WAS RESURFACED. AND DEPUY BONE CEMENT WAS UTILIZED. NO COMPLICATIONS WERE REPORTED. COMORBIDITY IDENTIFIED BMI: 29.98. ON (B)(6) 2020, LEFT KNEE WAS REVISED TO ADDRESS PAIN, TIBIAL BASEPLATE ASEPTIC LOOSENING (AT CEMENT IMPLANT INTERFACE), AND KNEE ARTHROFIBROSIS. THE FEMUR WAS NOT GROSSLY LOOSE AND WAS REMOVED WITH INSTRUMENTS. THE TIBIAL BASE PLATE WAS GROSSLY LOOSE, HAVING COMPLETELY DEBONDED FROM THE CEMENT MANTLE. THE TIBIAL BASE PLATE REPORTEDLY SUBSIDED 5 TO 8MM. THE PATELLA WAS RETAINED. SYNOVECTOMY PERFORMED. COMPETITOR KNEE REVISION SYSTEM WITH COMPETITOR CEMENT UTILIZED FOR TREATMENT. DOI: (B)(6) 2017 DOR: (B)(6) 2020. (LEFT KNEE).

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

  MAUDE report 9986694 ↗
• 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 PAIN, STIFFNESS, DECREASED RANGE OF MOTION, AND AN OVERSTUFFED KNEE. THE TIBIAL INSERT WAS REVISED. THE SURGEON NOTED THE PATELLA COMPONENT WAS REMOVED BUT NOT REPLACED TO FURTHER REDUCE THE OVER STUFFING AND STIFFNESS. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE NOT REVISED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2015. DOR: (B)(6) 2016; RIGHT KNEE.

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

  MAUDE report 9278638 ↗
• 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, AND DIFFICULTY WALKING. THE SURGEON NOTED ALL COMPONENTS WERE WELL-FIXED. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS NOT REVISED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION.. DOI: (B)(6) 2014. DOR: (B)(6) 2016. RIGHT KNEE.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 9273373 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. ON (B)(6) 2014, THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA DUE TO PAIN, DISCOMFORT, STIFFNESS, SWELLING, AND ARTHROFIBROSIS. NO PRODUCTS WERE REVISED DURING THE PROCEDURE. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO STIFFNESS AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA WAS NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014. DOE: (B)(6) 2014. DOR: (B)(6) 2018. RIGHT KNEE.

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

  MAUDE report 9268507 ↗
• InjuryOct 10, 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 SIGNIFICANT ARTHROFIBROSIS, PRE-OPERATIVE KNEE FLEXION OF 70 DEGREES, NO FEMORAL ROLLBACK WITH FLEXION DUE TO SIGNIFICANT SCARRING AND PCL TIGHTNESS, FLEXION GAP NOTABLY TIGHTER THAN EXTENSION GAP, AND INSTABILITY. THE SURGEON REMOVED ABUNDANT SCARRING. THE SURGEON NOTED THE PATELLAR FEMORAL TRACKING WAS SUB OPTIMAL WITH LATERAL TILT, LATERAL SUBLUXATION, AND NOTABLE LATERAL PATELLAR FACET OVERHANG EXACERBATED BY SIGNIFICANT LATERAL SCARRING. THE SURGEON ATTEMPTED TO RELEASE THE PCL OFF THE FEMUR TO SEE IF IT WOULD MAKE THE FLEXION GAP CLOSER TO THE EXTENSION GAP BUT IT WAS NOT ENOUGH TO BE SATISFACTORY. THE DECISION WAS MADE TO REMOVE THE COMPONENTS TO ALLOW ALL OPTIONS FOR OPTIMIZED BALANCING. THERE WAS NO LOOSENING. THE PATELLA COMPONENT WAS NOT REVISED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2016; DOR: (B)(6) 2017; RIGHT KNEE.

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

  MAUDE report 9176955 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT TOTAL KNEE REVISION TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REVISION: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 9084862 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE INCLUDING WASHOUT INFECTED TKR AND REVISION OF POLY/BEARING ATTUNE PROSTHESIS. THE ORIGINAL SURGERY WAS ON (B)(6) 2018. THE PATIENT ACQUIRED A HOSPITAL (B)(6) INFECTION. THE RIGHT KNEE WAS WASHED OUT THE POLY BEARING WAS CHANGED AND DISCARDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY OR ADDITIONAL PATIENT CONSEQUENCES.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8330607 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED MEDICAL RECORDS ON 06/26/2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. RIGHT ATTUNE TOTAL KNEE REVISED TO ADDRESS PAIN AND INSTABILITY. REVISING SURGEON NOTED THAT THE PCL WAS INCOMPETENT, ON A CR NON-STABILIZED KNEE REPLACEMENT. ATTUNE FEMUR, TIBIAL TRAY, AND TIBIAL INSERT COMPONENTS WERE REVISED TO COMPETITOR PRODUCTS; THE ATTUNE PATELLA COMPONENT WAS RETAINED. COMPETITOR CEMENT WAS USED DURING THE PRIMARY SURGERY. DOI: (B)(6) 2016; DOR: (B)(6) 2017; (RIGHT KNEE).

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7901392 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS PAINFUL KNEE WITH LIMITED MOTION. DOI: (B)(6) 2014; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Adhesion(s); Discomfort; Edema; Loss of Range of Motion; Muscular Rigidity; No Code Available; Not Applicable; Pain

  MAUDE report 7897386 ↗
• InjuryDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT KNEE BECAME SWOLLEN AND PAINFUL. THEY WERE WORKED UP BY INFECTIOUS DISEASE AND DETERMINED TO HAVE AN INFECTED TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND REPLACED WITH A TEMPORARY SPACER. DOI: UNKNOWN; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Pain; Swelling; Unspecified Infection

  MAUDE report 7099506 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6820053 ↗