ATTUNE 1516-40-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295050247), received between May 30, 2018 and Jan 6, 2026 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POLY SWAP, THE PATIENT COULDN'T GET FULL EXTENSION. WENT FROM 10MM DOWN TO 5MM. THERE WAS MUCH IMPROVEMENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 23973145 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS EXCHANGED BECAUSE OF INFECTION. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23347595 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT STRUGGLED WITH PAIN POSTOPERATIVELY AND DID NOT REHAB WELL POST BILATERAL TKAS. LEFT KNEE IS STIFF AND LACKS MOTION. ALL COMPONENTS WERE WELL ALIGNED AND WELL FIXED. A THINNER INSERT WAS TRAILED AND MOTION WAS FOUND TO BE QUITE GOOD AFTER SCAR TISSUE WAS REMOVED. THERE WAS NO DELAY OR PATIENT HARM. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

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

  MAUDE report 20846305 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DR. PERFORMED A POLY INSERT SWAP. HE REMOVED THE ORIGINAL IMPLANT AND WASHED OUT THE WOUND AND EXCHANGED IT FOR A NEW ONE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940682 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: ON (B)(6) 2021, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19459633 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS A 30-MINUTE SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 18996595 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT A LINER EXCHANGE DUE TO INFECTION. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17662037 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17106086 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16867995 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16571995 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16131707 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO REPORTED LOOSENING. UNKNOWN IF ANY SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14468785 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14461380 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2021 DOR: (B)(6), 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14102698 ↗
• MalfunctionDec 7, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT WOULD NOT ENGAGE AND SEAT IN THE TIBIA TRAY. SURGICAL DELAY 3 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 12955091 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A FEMORAL REVISION DUE TO INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12562647 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO INSTRUMENTS BROKE DURING SURGERY.

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

  MAUDE report 11207296 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 25 NOV 2020 WERE REVIEWED. ON (B)(6) 2016, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LEFT KNEE OSTEOARTHRITIS. DEPUY COMPONENTS INCLUDING DEPUY PATELLA WERE IMPLANTED WITH COMPETITOR CEMENT X2. THERE WERE NO COMPLICATIONS REPORTED. ON (B)(6) 2020, THE PATIENT HAD A REVISION LEFT TOTAL ARTHROPLASTY WITH REVISION OF FEMORAL AND TIBIAL COMPONENTS TO ADDRESS FAILED LEFT TOTAL KNEE ARTHROPLASTY WITH LOOSE TIBIAL COMPONENT. DURING THE PROCEDURE THE SURGEON OBSERVED OSTEOLYSIS AROUND THE FEMORAL COMPONENTS. THE FEMORAL COMPONENT WAS NOT GROSSLY LOOSE, BUT WAS REMOVED. THERE WAS BONE LOSS ABOUT THE MEDIAL ASPECT OF THE TIBIAL COMPONENT. THERE WAS NO LOOSENING INTERFACE PROVIDED FOR THE LOOSE TIBIAL TRAY. THE PATELLA WAS NOTED TO BE WELL-FIXED AND TRACKING WELL. THE PATELLA WAS NOT REVISED. DEPUY COMPONENTS WERE IMPLANTED ALONG WITH COMPETITOR CEMENT DURING THIS REVISION. DOI: (B)(6) 2016 DOR: (B)(6) 2020 (LEFT KNEE).

  Patient problems: Osteolysis

  MAUDE report 11020058 ↗
• MalfunctionOct 29, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED SURGEON WAS TRYING TO IMPLANT NEW FIXED BEARING POLY AND IT WAS NOT LOCKING IN CORRECTLY. SURGEON WAS CONCERNED THAT LOCKING MECHANISM ON INSERT WAS DAMAGED AND WANTED A NEW ONE THAT WAS NOT COMPROMISED. A NEW POLY WAS OPENED. PLEASE REPLACE THIS ITEM TO MY INVENTORY AT MERCY. DOE: (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10756843 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS BEING REVISED FOR SUSPECTED INFECTION. STAT CULTURES WERE NOT FINISHED BEFORE THE CASE WAS OVER, CAN'T CONFIRM INFECTION. HOWEVER, THE SURGEON DECIDED TO EXPLANT ENTIRE KNEE AND FOUND MASSIVE CYSTS BEHIND BOTH THE TIBIAL BASEPLATE AND FEMUR. A KASM ANTIBIOTIC SPACER WAS IMPLANTED. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: (B)(6) 2015; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9710024 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2016, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY. THE SURGEON REPORTED THE USE OF FLEXIBLE OSTEOTOME TO BREAK UP THE CEMENT INTERFACE ON THE FEMUR AS WELL AS THE TIBIAL COMPONENT. HE REPORTED GOOD PATELLOFEMORAL TRACKING AND THE PATELLA WAS RETAINED FOR OFF USE. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2016.

  Patient problems: No Code Available

  MAUDE report 9488939 ↗
• InjuryOct 3, 2019Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 12 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. IT WAS NOTED THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS AND PATIENT WAS TRANSFERRED TO RECOVERY IN SATISFACTORY CONDITION. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND DEPUY BONE CEMENT X 2. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, AND PAIN. THE SURGEON INDICATED THERE WAS SYNOVITIS CONSISTENT WITH POLYETHYLENE WEAR AND LOOSENING. HE NOTED THE FEMUR WAS NOT LOOSE, THOUGH REVISED. THE TIBIAL COMPONENT WAS LOOSE AND THERE WAS NO CEMENT ADHERENCE AT THE CEMENT/BONE INTERFACE NOR THE CEMENT / IMPLANT INTERFACE. IT WAS NOTED THE PATELLA TRACKED WELL AND NO RELEASES WERE NECESSARY. THE PATELLA WAS NOT REVISED. THE SURGEON REPORTED TISSUE SPECIMEN CAME BACK AS HAVING CHRONIC INFLAMMATION BUT NO EVIDENCE OF ACUTE INFLAMMATION OR BACTERIA. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2014. DOR: (B)(6) 2018, (RT KNEE).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9153014 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND LOOSENING OF THE TIBIAL TRAY COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2016 DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8976981 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED KNEE. POLY SWAP WAS DONE. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8773129 ↗
• InjuryNov 2, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8032973 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507