ATTUNE 1517-10-408Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295055808), received between Dec 28, 2018 and May 4, 2026 — classified as 20 injuries.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED DUE TO ARTHROFIBROSIS. SCAR TISSUE REMOVED AND POLY WAS DOWNSIZED. NOTHING FURTHER TO REPORT. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Arthrofibrosis

  MAUDE report 25071503 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN NOT RESOLVING AS EXPECTED IN REVISION KNEE/PLAN TO PERFORM REVISION: DEVICE (RELATEDNESS): DEFINITELY NOT, PROCEDURE (RELATEDNESS): PROBABLY, DATE OF EVENT: 03 JUL 2020, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: (B)(6) 2022, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION OF THE STUDY KNEE TIBIAL TRAY, TIBIAL STEM, AND TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 21984018 ↗
• InjuryMar 20, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A PRIMARY TKA WITH THE ATTUNE CRS INSERT IN QUESTION FOR KNEE OA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SPIN-OUT OF THE INSERT OCCURRED. ON (B)(6) 2025, THE INSERT IN QUESTION WAS REPLACED TO 18MM INSERT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 21654273 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED, FOR RIGHT KNEE MOBILIZATION: DEVICE (RELATEDNESS): POSSIBLY. PROCEDURE (RELATEDNESS): PROBABLY. DATE OF EVENT: (B)(6) 2024. DATE OF REVISION: NO REVISION. DATE OF IMPLANT: (B)(6) 2024. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION/CLOSED REDUCTION/MANIPULATION.

  Patient problems: Insufficient Information

  MAUDE report 20693255 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED BECAUSE OF INFECTION. UNKNOWN SURGICAL DELAY. DOI: ON (B)(6) 2024. DOR: ON (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20576692 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE MOBILIZATION. IS THIS EVENT RELATED TO THE STUDY DEVICE? POSSIBLY. IS THIS EVENT RELATED TO THE STUDY PROCEDURE? PROBABLY. DEVICE LOCATION: RIGHT. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: (B)(6) 2024. TREATMENT/IMPACT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 20278245 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE. PATIENT FELL A FEW DAYS AFTER POST OP. THEY GOT A LATERAL PLATE WITH SCREWS. KNEE BECAME INFECTED. DOING A POLY SWAP. DOI- (B)(6) 2024 DOR- (B)(6) 2024 AFFECTED SIDE- RIGHT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 19483175 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NEW FEMUR AND INSERT IMPLANTED. NO FURTHER INFORMATION AVAILABLE. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 14397407 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN NOT RESOLVING AS EXPECTED IN KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2021; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: THE REVISION OCCURRED ON (B)(6) 2022. THE CLINICAL DATABASE INDICATES THE FEMORAL SIDE DEVICES AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 14140925 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION DUE TO PAIN AT THE DISTAL TIP OF THE STEM IN THE TIBIA. PATIENT VERY UNHAPPY AND SURGEON PLANNED TO REVISE THE TIBIA COMPONENT, BUT THEN NEEDED TO CHANGE THE FEMORAL COMPONENT ALSO. PATIENT HAS HAD MULTIPLE SURGERIES (B)(6) 2021 THEN AGAIN ON (B)(6) 2021. THIS PC IS THE THIRD REVISION. DOI: UNKNOWN. DOR (1ST): (B)(6) 2021 (REVISION OF COMPETITOR PRODUCTS). DOR (2ND): (B)(6) 2021. DOR (3RD): (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 13869313 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO TREAT INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS UTILIZED. PATIENT RECEIVED A TEMPORARY SPACER. DOI: (B)(6) 2019 DOR: (B)(6) 2021 UNKNOWN KNEE.

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

  MAUDE report 11838970 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY KNEE JOINT RIGHT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2021; (RIGHT KNEE). REVISION DUE TO INSTABILITY OCCURRED ON (B)(6) 2021. REVISION OF TIBIAL INSERT ONLY.

  Patient problems: Joint Laxity

  MAUDE report 11744296 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DEBRIDEMENT AND IRRIGATION PERFORMED. INSERT WAS CHANGED AND THE REST OF THE IMPLANTS WERE RETAINED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9874082 ↗
• InjuryMar 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE DISLOCATION (DUE TO LIGAMENT LAXITY DUE TO SWELLING AND LYMPHEDEMA). EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Edema; Joint Dislocation; No Code Available

  MAUDE report 9843068 ↗
• InjuryMar 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO FALL. FEMUR JUMPED THE POST. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Fall; No Code Available; Pain

  MAUDE report 9836498 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNK; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8772452 ↗
• InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE INFECTION EVENT IS SERIOUS AND IS CONSIDERED MODERATE AND ONGOING EVENT IS REMOTELY POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2019; DOE: (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8628916 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE 03MAY2019: CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTED TOTAL KNEE ARTHROPLASTY. DOI: (B)(6) 2019. DOR: (B)(6) 2019; (LEFT KNEE). INSERT REVISED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8623313 ↗
• InjuryMay 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8617231 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED VIA TKA (DATE OF PRIMARY SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE SURGEON RECOGNIZED INFECTION AFTER THE REVISION SURGERY (DATE OF REVISION SURGERY WAS UNKNOWN) THUS, THE 2ND REVISION SURGERY WAS PERFORMED BY WASHING OUT THE DEBRIS AND REPLACING THE LINER (P/N: 151710408). THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8203146 ↗