ATTUNE 1516-40-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295049821), received between Jan 15, 2018 and Jun 12, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POOR MOTION POST SURGERY DUE TO ISSUES WITH PT DURING HER RECOVERY. A POLY EXCHANGE AND SCAR REMOVAL WAS PERFORMED ON A WELL ALIGNED AND WELL FIXED TKA. STABILITY AND ROM WAS FOUND TO BE IMPROVED. NO DELAY AND NO PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2023. DOR: (B)(6) 2026 . AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 25488149 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25123167 ↗
• InjuryApr 3, 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 INSTABILITY OF LEFT KNEE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21761982 ↗
• InjuryNov 5, 2024Adverse 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. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20612360 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN THE JOINT THAT COULD NOT BE SOLVED WITH A WASHOUT. ATTUNE KNEE WAS REMOVED SO THAT AN ANTIBIOTIC SPACER COULD BE IMPLANTED TO FIGHT THE INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18558016 ↗
• InjuryJul 13, 2023Adverse 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 INSTABILITY. DOI: UNKNOWN. DOR: (B)(6)2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 17314784 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16139377 ↗
• InjuryJan 5, 2023Adverse 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. NO ADDITIONAL INFORMATION WAS REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16102017 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO JOINT INFECTION. POLY SWAP WAS PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12704882 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED INDICATED THAT "DOI: (B)(6) 2016: PATIENT RECEIVED A RIGHT PRIMARY ATTUNE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PRIMARY IMPLANTS: ATTUNE PCL SUBSTITUTING FEMORAL COMPONENT SIZE 4. FIXED-BACK TIBIAL TRAY SIZE 4. POSTERIOR STABILIZING INSERT SIZE 2 X 10 MM. PATELLA SIZE 38 MM. DOR: (B)(6) 2021: PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN, INSTABILITY, SWELLING, NUMBNESS, WEAKNESS, AND STIFFNESS SECONDARY TO TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE SURGEON EVACUATED EFFUSION. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE CEMENT MANTLE ON THE MEDIAL SIDE OF THE TIBIA WAS CRACKED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE PATELLA AS IT WAS WELL-FIXED, BUT IT WAS REVISED DUE TO A CRACK ON THE PATELLAR CEMENT MANTLE. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE FEMORAL COMPONENT WAS WELL-FIXED AND RETAINED. THE PATIENT RECEIVED ATTUNE REVISION PRODUCTS THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. RECORDS INDICATE THE PATIENT RECEIVED A LEFT PFC SIGMA TKA ON (B)(6) 2

  Patient problems: Fatigue; Joint Laxity; Muscular Rigidity; Numbness; Pain; Swelling/ Edema

  MAUDE report 12526703 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT A SECOND LEFT KNEE REVISION TO ADDRESS PAIN. THE SURGEON NOTED THE REMOVAL OF SCAR TISSUE. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE SURGEON NOTED MINIMAL BONE LOSS WITH REMOVAL OF THE FEMORAL COMPONENT. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2018 INSERT; DOI: (B)(6) 2017 FEMORAL, TIBIAL TRAY; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12290243 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 02 FEB 2021 WERE REVIEWED. ON (B)(6) 2014, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY COMPONENTS INCLUDING DEPUY PATELLA WERE USED DURING THIS PROCEDURE. COMPETITOR CEMENT WAS USED. NO COMPLICATIONS WERE NOTED IN THE OPERATIVE NOTES. ON (B)(6) 2018, THE PATIENT HAD A REVISION TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL TRAY, NO INTERFACE PROVIDED. DURING THE PROCEDURE, THE SURGEON OBSERVED HYPERTROPHIC SYNOVIUM WITH A GRAYISH BLACK PIGMENTATION, AND EXTENSIVE SYNOVITIS. THE PATELLA WAS NOTED TO BE STABLE WITH MILD HYPERTROPHIC DISCOLORED SYNOVIUM AROUND THE PATELLA COMPONENT, BUT WAS NOT REVISED. THE TIBIAL TRAY, FEMORAL COMPONENT AND INSERT WERE REVISED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; (LEFT KNEE).

  Patient problems: Local Reaction; Pain; Synovitis

  MAUDE report 11447482 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MCL LOOSENING. POLY SIZE INCREASED FOR STABILITY. NO IMPLANT LOOSENING REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11201175 ↗
• InjuryFeb 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED AT CLINIC UNABLE TO FLEX FULLY. ON XRAY THE FIXED BEARING POLY INSERT HAD DISENGAGED FROM TIBIAL BASE. OPERATING CONSULTANT WOULD LIKE TO ENSURE THAT THERE WASN¿T A MECHANICAL FAULT WITH THE LOCKING MECHANISM.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9667127 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY FOLLOWING A FAILED UNICOMPARTMENTAL KNEE ARTHROPLASTY WITH UNKNOWN COMPONENTS AND UNKNOWN DATE, DUE TO PAIN AND OSTEOARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM, AND COMPETITOR BONE CEMENT. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT KNEE REVISION OF LYSIS OF SCAR TISSUE AND POLYETHYLENE EXCHANGE, DUE TO STIFFNESS. THE SURGEON REPORTED THE PATIENT DID NOT HAVE A PATELLA FROM A PREVIOUS PATELLECTOMY PROCEDURE. HE NOTED LYSIS OF ADHESIONS IN THE MEDIAL AND LATERAL GUTTERS, AND THE REMOVAL OF THE POLYETHYLENE SPACER. HE REPORTED THE FEMORAL AND TIBIAL COMPONENTS WERE WELL-FIXED AND APPEARED WELL-ALIGNED. THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2015; (RT KNEE).

  Patient problems: Adhesion(s); Loss of Range of Motion; No Code Available; Osteolysis

  MAUDE report 9476563 ↗
• InjuryApr 26, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE TIBIA WAS FOUND TO BE GROSSLY LOOSE WITH NO CEMENT ADHERENCE. PITTING OF THE POLY INSERT WAS ALSO NOTED. THE PATIENT WAS REVISED TO A FULL SIGMA KNEE REVISION. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8557624 ↗
• InjuryApr 10, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION TOTAL KNEE ARTHROPLASTY OVER ATTUNE PRIMARY TOTAL KNEE FIXED BEARING DUE TO PATIENT DISSATISFACTION AND PAIN. THE SURGEON REMOVED BOTH FEMORAL AND TIBIAL COMPONENTS WITHOUT ISSUE, THEY WERE WELL FIXED. THEY DID TAKE SOME EFFORT TO REMOVED EVEN FORMED THE REVISION PROCEDURE AND SATISFIED WITH THE RANGE MOTION OF THE PATIENT. IT DID INVOLVED A PATIENT. LEFT KNEE

  Patient problems: No Code Available; Pain

  MAUDE report 8500254 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS ACUTE INFECTION. POLY SWAP AND WASH OUT WAS DONE. DOI: (B)(6) 2018; DOR: (B)(6) 2019; UNKNOWN KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8270649 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL DER RECEIVED AN AE FOR GLOBAL INSTABILITY OF THE RIGHT KNEE. EVENT DOES MEET THE DEFINITION OF SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. TREATMENT INCLUDES REVISION OF INSERT. DOI: (B)(6) 2014, DOR: (B)(6) 2016, AE: (B)(6) 2016, RIGHT KNEE.

  Patient problems: Discomfort; Inflammation; Pain

  MAUDE report 7189196 ↗

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