ATTUNE 1516-40-810Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295050384), received between Dec 11, 2017 and Sep 8, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT KNEE WAS INFECTED. JOINT WASHED OUT FOR SECOND TIME AND INSERT EXCHANGED FOR SAME SIZE. THERE WERE NO DELAYS OR PATIENT INJURY. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22993922 ↗
• InjurySep 4, 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 INFECTED TOTAL KNEE. THE INSERT WAS EXCHANGED AND KNEE WAS WASHED OUT. NO DELAYS OR PATIENT INJURY. THERE WAS NO LOOSENING. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22961621 ↗
• InjuryJul 10, 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 SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22468187 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INFECTED KNEE. POLY WAS SWAPPED. DOI: UNKNOWN. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 21930413 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR A STIFF KNEE. SURGEON SIZED DOWN ON THE POLY THICKNESS TO HELP PATIENT GET FULL EXTENSION. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Muscular Rigidity

  MAUDE report 20733994 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 19280622 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY IN TOTAL KNEE ARTHROPLASTY. SURGEON ALSO UPSIZED INSERT. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18433970 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POOR RANGE OF MOTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 15198974 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR INFECTION. I AND D WITH POLY EXCHANGE WAS DONE. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11819934 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SATURDAY, (B)(6), SURGEON CONTACTED THE REPORTING SALES REPRESENTATIVE TO INFORM HIM THAT A PATIENT HAD PRESENTED IN CLINIC RECENTLY WITH WHAT HE SUSPECTED WAS AN INFECTED LEFT KNEE AND HIS PLAN WAS TO DO AN I&D WITH A POSSIBLE POLY EXCHANGE DEPENDING ON THE RESULT OF LAB WORK HE HAD ORDERED FOR THE PATIENT. BASED ON SIGNS OF AN INFECTION FROM THE LAB RESULTS, SURGEON ELECTED TO PERFORM A LEFT KNEE I&D/POLY EXCHANGE ON WEDNESDAY, (B)(6) AT (B)(6) HOSPITAL. THE PATIENT¿S INDEX SURGERY WAS PERFORM IN LATE 2018 AT (B)(6). SURGEON EXPOSED THE KNEE JOINT AND REMOVED THE INDEX TIBIAL INSERT WITH AN OSTEOTOME AND THEN PROCEEDED TO DEBRIDE AND IRRIGATE THE KNEE. SURGEON THEN TRAILED DIFFERENT POLY THICKNESSES AND ELECTED TO REPLACE WITH A NEW TIBIAL INSERT WITH THE SAME THICKNESS AS THE ONE HE TOOK OUT. ALL OTHERS COMPONENTS FROM INDEX SURGERY WERE TESTED FOR LOOSENESS AND FOUND TO BE WELL FIXED SO HE ELECTED TO KEEP THEM IN THE PATIENT. SURGEON MENTIONED LAB RESULTS SHOWED SIGNS OF A STREP (STAPH) INFECTION. THERE WAS NO DELAYS IN THE CASE. NO INSTRUMENTATION BROKE. THERE WAS NO INDICATION BY ANYONE THAT THE PRODUCTS DID NOT PERFORM AS THEY WERE SUPPOSED TO. THERE WAS NO LOOSENING OF A

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

  MAUDE report 11412106 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017: PATIENT UNDERWENT A RIGHT KNEE REPLACEMENT DUE TO DJD. ATTUNE IMPLANTS WERE PLACED WITH DEPUY CEMENT. ON (B)(6) 2019: PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO PARTIAL DEBONDING OF THE TIBIAL TRAY. THE FEMORAL COMPONENT WAS ALSO FOUND TO HAVE EARLY LOOSENING (UNKNOWN INTERFACE). THERE WAS SLIGHT INTERNAL ROTATION OF THE FEMORAL COMPONENT WHICH CAUSE SLIGHT LATERAL TRACKING OF THE PATELLA. A LARGE EFFUSION (150MLS) WAS FOUND AS WELL AS GLOBAL INSTABILITY. DOI: (B)(6) 2017, DOR: (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Edema; No Code Available

  MAUDE report 9824195 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018: THE PATIENT UNDERWENT RIGHT KNEE REVISION DUE TO PAIN AND INSTABILITY. INTRAOPERATIVELY, SURGEON NOTES SIGNIFICANT AMOUNT OF SCAR TISSUE REQUIRING REMOVAL AND LAXITY IN BOTH FLEXION AND EXTENSION PLANES. ONLY THE POLY INSERT WAS EXCHANGED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2019: THE PATIENT UNDERWENT RIGHT KNEE REVISION DUE TO PAIN. INTRAOPERATIVELY SURGEON NOTES "LARGE AMOUNT" OF ADHESION TISSUE UNDERNEATH THE QUADRICEPS AND PATELLAR TENDON. PATELLA AND FEMORAL COMPONENT FOUND WELL FIXED. SURGEON NOTES EXTRACTION OF TIBIAL COMPONENT DUE TO REPORTED PAIN IN REGION AND FOUND REMOVAL OF TIBIAL COMPONENT FROM CEMENT MANTLE "EASY" AND RELATIVELY CLEAN WITH NO SIGNIFICANT CEMENT ATTACHED TO TIBIAL FACEPLATE INDICATING LOOSE TIBIAL PLATE AT IMPLANT-CEMENT INTERFACE. THE TIBIAL PLATE AND INSERT WERE REPLACED. NO INTRAOPERATIVE COMPLICATIONS NOTED. DOI: (B)(6) 2016 (TIBIAL TRAY, INSERT AND PATELLAR COMPONENT). DOR 1ST: (B)(6) 2018 (TIBIAL INSERT). DOR 2ND: (B)(6) 2019 (RT KNEE).

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

  MAUDE report 9565853 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH REMOVAL OF TOTAL KNEE COMPONENTS AND PLACEMENT OF ANTIBIOTIC-IMPREGNATED SPACER DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2014; DOR: (B)(6) 2014; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9321410 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LIMITED RANGE OF MOTION AND PAIN. SYNOVECTOMY AND POLY EXCHANGE WERE DONE. DOI: (B)(6) 2018. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8598942 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. ALL COMPONENTS WERE WELL FIXED. SURGEON REMOVED FEMUR TIBIA AND INSERT AND REPLACED WITH AN ATTUNE REVISION KNEE WITH SLEEVES ON BOTH SIDES. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT SIDE.

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

  MAUDE report 8353469 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AFFECTED SIDE IS THE LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8315667 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2015. DOR: (B)(6) 2016; RIGHT KNEE.

  Patient problems: Edema; Joint Disorder; Osteolysis; Pain

  MAUDE report 7633708 ↗
• InjuryMay 23, 2018Off-Label Use; Off-Label Use

  DER STATES THAT SIZE 8FB TRAY AND SIZE 7 PS FEMUR WAS IMPLANTED. SIZE 8X10MM INSERT WAS IMPLANTED AND REALIZED NEXT DAY. DOI: (B)(6) 2018 DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7536793 ↗
• InjuryApr 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7471856 ↗
• InjuryMar 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  POLY EXCHANGE FOR WASH OUT - INFECTION.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7381359 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017 ; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7103906 ↗

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