ATTUNE 1516-50-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295052333), received between Jun 26, 2018 and Mar 13, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED CONTINUOUS KNEE PAIN FOLLOWING A TOTAL KNEE PROCEDURE. DURING A SUBSEQUENT SURGERY, THE DECISION WAS MADE TO RESURFACE THE PATELLA AND UPSIZE THE POLYETHYLENE INSERT FROM THE PREVIOUS SIZE. THE ORIGINAL INSERT WAS REMOVED AND REPLACED WITH A NEW, THICKER INSERT.

  Patient problems: Pain

  MAUDE report 24591955 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO A THICKER POLY AND PATELLA WAS SWAPPED. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20460996 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 19072134 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR SUDDEN ONSET OF SWELLING. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022 DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 18687642 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO TOO MUCH HYPER EXTENSION. THE POLY WAS UPSIZED WITH A CRS POLY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16796195 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASPIRATION OF STUDY KNEE (RIGHT) - CONFIRMATION OF LOOSENING TIBIAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: ASPIRATION OF KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14073466 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASPIRATION OF STUDY KNEE - AS A RESULT OF RAISED CRP AND INFECTION - CONFIRMATION OF LOOSENING TIBIAL COMPONENT? UNCONFIRMED CURRENTLY EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: ARTHROSCOPY, ARTHROSCOPIC BIOPSIES TO CONFIRM INFECTED TOTAL KNEE; ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 13939583 ↗
• InjuryFeb 22, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THIS PATIENT HAD A RIGHT TOTAL KNEE THAT WAS PAINFUL. THE PATIENT WAS NONCOMPLIANT AND HAD MULTIPLE FALLS. THE PATIENT HAD BLOWN OUT HER MCL AND PATELLA TENDON. WHEN THE SURGEON OPENED THE KNEE UP, IT WAS DISCOVERED THAT THE TIBIAL INSERT HAS SPUN 180DEG BACKWARDS AND THE PATIENT HAD BEEN WALKING WITH THE KNEE INSERT IN THIS POSITION. THE COMPONENTS ARE WELL FIXED, SO THE SURGEON DID AN INSERT EXCHANGE. THERE IS NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Pain; Unspecified Musculoskeletal problem

  MAUDE report 13576598 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN I&D AND A POLY SWAP WERE PERFORMED DUE TO INFECTED TKA. THIS IS THE ONLY INFORMATION AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12892065 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. ONLY A DEBRIDEMENT WAS PERFORMED OF SCAR TISSUE AND A POLY EXCHANGE WAS DONE. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Scar Tissue

  MAUDE report 12481263 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED PRIMARY RIGHT KNEE ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE SURGEON NOTES THAT THE PATIENT HAS A LONG HISTORY OF RIGHT KNEE INSTABILITY AND PAIN WITH MULTIPLE RIGHT KNEE SURGERIES INCLUDING A FULLERTON TIBIAL OSTEOTOMY FOR PATELLAR REALIGNMENT, ACL RECONSTRUCTION, A MEDIAL MENISCECTOMY AND A LATERAL MENISCECTOMY. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 1 WAS UTILIZED. THE SURGEON NOTES THAT THE PATIENT HAD RESIDUAL TIGHTNESS IN EXTENSION, WHICH WAS REPAIRED WITH PIE CRUSTING OF THE IT BAND. THE TIBIAL TUNNEL FROM THE PREVIOUS ACL RECONSTRUCTION WAS STILL PATENT AND CAREFULLY PLUGGED. AFTER FINAL IMPLANTATION, THE SURGEON NOTES THERE WAS MILD RESIDUAL MEDIAL LAXITY WHICH HE DEEMED ACCEPTABLE FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. (B)(6) 2019: PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN AND GLOBAL INSTABILITY SECONDARY TO TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED PERIARTICULAR SYNOVITIS AND EVACUATED JOINT EFFUSION. THE TIBIAL TRAY WAS GROSSLY LOOSE AND PARTIALLY DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTES THAT THERE WAS ALSO LOOSENING AT THE TIBIAL BONE TO COMPETITOR CEMENT INTE

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

  MAUDE report 11673470 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11567963 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT KNEE REVISION TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF REVISION: (B)(6) 2020, (RIGHT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: No Code Available

  MAUDE report 10426918 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE PAIN POST TKR REVISION AT TIBIA AND INFLAMMATION OF ITB AT GERDY'S TUBERCLE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2018; DOE: (B)(6) 2019 (ONSET); (RIGHT KNEE).

  Patient problems: Inflammation; No Code Available; Pain

  MAUDE report 9396838 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN WITH AN UNSTABLE KNEE. DOI: (B)(6) 2017, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8609324 ↗
• InjuryJun 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT IT WAS A POLY EXCHANGE OF A SIGMA PS ROTATING PLATFORM. SURGEON DISCOVERED UNUSUAL INSTABILITY PRIOR TO INCISION. POST INCISION, DISCOVERED THE INSERT WAS TURNED 180 DEGREES. SURGEON COMMENTED HE DIDN'T KNOW HOW IT COULD HAVE SPUN AROUND. DOI : (B)(6) 2011, DOR: (B)(6) 2018, UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable

  MAUDE report 7637866 ↗