ATTUNE 1516-20-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295045922), received between Nov 8, 2017 and Feb 24, 2026 — classified as 20 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 24, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING ANTIBIOTIC SPACER. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24433075 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSERT WAS REMOVED AND REPLACED WITH A THICKER OPTION BECAUSE OF LAXITY. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23771113 ↗
• InjurySep 15, 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 PAIN. AFFECTED SITE - LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23053186 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INCISION AND DRAINAGE WITH POLY EXCHANGE ON (B)(6) 2023 AS WELL AND HAD BEEN FIGHTING DRAINAGE. SURGEON ELECTED TO REMOVE AND PLACE A SPACER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22555365 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A POLY SWAP DUE TO POSSIBLE INFECTION AND PAIN. THERE WAS NO SURGICAL DELAY. THE INFECTION WAS NOT CONFIRMED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21996063 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT KNEE POLY SWAP FROM 7X10 FBCR TO 7X12 FBCR. POSSIBLE INFECTION BUT ALSO INSTABILITY OF LEFT KNEE. THERE WAS NO ABNORMAL WEAR NOTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022; DOR- (B)(6) 2024; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 20672606 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SEVERE LAXITY. IT WAS SUSPECTED AS PCL DEFICIENCY. ATTUNE IMPLANTS WERE REMOVED. LIGAMENTS AND STABILITY WERE VERY COMPROMISED. S-ROM NOILES HINGE WAS IMPLANTED. NOW, IT WAS WELL BALANCED AND STABLE. THERE WAS NO SURGICAL DELAY. DOI: ON (B)(6) 2018, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16375019 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT ATTUNE TKR REVISION - SUSPECTED INFECTION. SURGEON COMPLETED WASHOUT, DEBRIDEMENT AND POLY EXCHANGE. ORIGINAL SURGERY COMPLETED BY DR (B)(6) 2017 - (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 16204415 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION DUE TO INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15966502 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO PAIN AND LIGAMENTOUS LAXITY WITH HYPEREXTENSION. TIBIAL INSERT WAS EXCHANGED TO A 12MM INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13110795 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2021. (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 12623020 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED OF THE POLYSWAP DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10785850 ↗
• InjuryJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING. LOOSENING OCCURRED AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. ON (B)(6) 2013: THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. ATTUNE IMPLANTS WERE UTILIZED WITH UNKNOWN MANUFACTURER CEMENT. PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2016: THE PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE FOR SUSPECTED LOOSENING. INTRAOPERATIVELY, SURGEON NOTED THE TIBIAL TRAY LOOSE AT IMPLANT-CEMENT INTERFACE. THE FEMORAL COMPONENTS WERE FOUND WELL FIXED. SURGEON NOTES OSTEOLYSIS AROUND EDGES OF PATELLA AND CLINICALLY DETERMINES ENOUGH BONE STOCK IS PRESENT TO REVISE PATELLA. ALL COMPONENTS (PATELLAR, FEMORAL, TIBIAL, INSERT) WERE REPLACED WITH DEPUY REVISION TC3 KNEE SYSTEM WITH UNKNOWN MANUFACTURER CEMENT. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2019: THE PATIENT UNDERWENT A REVISION UNDER DIFFERENT SURGEON OF THE RIGHT KNEE FOR SUSPECTED LOOSENING. MEDICAL RECORD DOES NOT INDICATE IF LOOSENING WAS CONFIRMED INTRAOPERATIVELY OR INDICATE ANY IMPLANT FAILURES. THE PATELLA WAS LEFT INTACT. ALL OTHER COMPONENTS (FEMORAL, FEMORAL FLUTED STEM, FEMORAL MEDIAL AND LATERAL AUGMEN

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9546925 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND DEPUY BONE CEMENT X 1. ON (B)(6) 2017 THE PATIENT UNDERWENT TOTAL LEFT KNEE MANIPULATION DUE TO ARTHROFIBROSIS. THE SURGEON REPORTED A MILD DEGREE OF CREPITUS WAS AUDIBLE. HE INDICATED FLEXION WENT FROM 72 DEGREES BEFORE THE PROCEDURE TO 110 DEGREES POST-SURGERY. THERE WERE NO REPORTED COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2017; DOR: (B)(6) 2017 (LT KNEE).

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9349456 ↗
• InjuryNov 4, 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 09 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS AND PAIN. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 1. ON (B)(6) 2016 THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY, OPEN REPAIR OF QUADRICEPS TENDON, POSTERIOR CRUCIATE LIGAMENT INJURY, AND PAIN. THE SURGEON INDICATED IN (B)(6) 2016, THE PATIENT INDICATED HE HEARD A POP IN THE RIGHT KNEE THEN DEVELOPED INSTABILITY. THE SURGEON REPORTED UPON ENTERING THE KNEE, HE ENCOUNTERED BLOOD AND IT LOOKED LIKE THE PATELLAR TENDON HAD RUPTURED RECENTLY. THE SURGEON REPORTED THE PATELLAR COMPONENT WAS STABLE. HE OFFERED NO CONCERNS REGARDING THE TIBIAL NOR FEMORAL COMPONENTS, THOUGH THEY WERE REVISED. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND DEPUY CEMENT X 2, AND THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2016. DOR: (B)(6) 2016 (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9272117 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS RECENTLY FELT SOME INSTABILITY IN HIS LEFT KNEE. HE WAS REVISED TO A THICKER POLY INSERT DO TO THIS INSTABILITY. THERE WAS NO LOOSENING OF THE METAL ATTUNE COMPONENTS. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE. UPDATE FROM MEDICAL RECORD REVIEW: MULTIPLE EVALUATION NOTES DATED BETWEEN THE PRIMARY AND REVISION INDICATED DISCOMFORT, SWELLING, HEMARTHROSIS, CYST, AND WALKING DIFFICULTY.

  Patient problems: Cyst(s); Discomfort; No Code Available; Swelling

  MAUDE report 8493289 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOTH REVISION CASES WERE PERFORMED DUE TO INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 8030223 ↗
• InjuryMay 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  FIRST STAGE KNEE REVISION THE SURGEON (B)(6) HOSPITAL (B)(6) 2018; PRIMARY (B)(6) 2017. FIRST STAGE REVISION (B)(6) 2018: SEVEN MONTHS POST PRIMARY SURGERY, PATIENT DEVELOPED HEAT AND SWELLING IN RIGHT KNEE. KNEE ASPIRATED (B)(6) 2018. NIL BACTERIAL GROWTH NOTED. PATIENT HAD REPORTS OF "CONTINUOUS ACHING" IN RIGHT KNEE. NIL SIGNS OF IMPLANT SUBSIDENCE, OR LOOSENING. FIRST STAGE REVISION WITH ANTIBIOTIC SPACER. NIL FURTHER DETAILS KNOWN. MALE PATIENT ID: (B)(6); D.O.B: (B)(6).

  Patient problems: Not Applicable; Pain; Swelling

  MAUDE report 7556879 ↗
• InjuryFeb 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION OF POLY SWAP. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN AFFECTED SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7297395 ↗
• InjuryNov 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT CHIEF COMPLAINT IS PAIN. THE SURGEON WENT IN AND REMOVED THE TIBIAL COMPONENT AND REPLACED IT WITH AN ATTUNE REVISION FIXED BEARING TIBIAL TRAY AND INSERT. SURGEON WENT UP ON THE POLY INSERT ONE THICKNESS. HE ALSO ASKED THAT I SEND THE EXPLANTED COMPONENTS TO (B)(6) TO BE STUDIED. THE FEMUR AND PATELLA WERE WELL FIXED AND NOT REMOVED.

  Patient problems: Pain

  MAUDE report 7010396 ↗