ATTUNE 1516-40-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10603295049791), received between Jan 26, 2018 and Sep 28, 2026 — classified as 40 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised for knee pain / possible infection. Explanted the Sz 4x6mm stabilize insert. Washed out knee and implanted new SZ 4x 7mm stabilized insert. No delay in surgery No injury to patient Left knee.Affected side: Left Knee.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50918248 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL CREATING INSTABILITY. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Joint Laxity

  MAUDE report 25871513 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY CAUSED BY MEDIAL TIBIAL TRAY SUBSIDENCE. DR. REMOVED THE PATIENT'S ATTUNE PRIMARY INSERT, FEMUR, AND TIBIAL TRAY. DR. REPLACEMENT THEM WITH ATTUNE REVISION IMPLANTS, TO INCLUDE A MEDIAL TIBIAL AUGMENT AND PRESS-FIT STEMS. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24520826 ↗
• InjuryDec 30, 2025Naturally Worn; Naturally Worn

  (B)\(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION FOR A PERIPROSTHETIC FRACTURE POST FALL. LOCATION OF FRACTURE IS NOT IDENTIFIED. THE ARTICULAR SURFACE OF THE REVISED INSERT SHOWS SEVERE PITTING AND MODERATE ABRASION

  Patient problems: Fall

  MAUDE report 23922600 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. PATIENT FELL AND HER INCISION OPENED UP.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 23755487 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ANTERIOR KNEE PAIN. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNK KNEE.

  Patient problems: Pain

  MAUDE report 19949521 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY INVOLVING ATTUNE COMPONENTS. THE PATELLA WAS RESURFACED AND SMARTSET CEMENT X 2 WAS USED. ON (B)(6) 2024, THE PATIENT UNDERWENT A LEFT KNEE REVISION FOR INSTABILITY. INTRAOPERATIVELY, THE TIBIAL COMPONENT WAS COMPLETELY DEBONDED AT AN UNKNOWN INTERFACE. THE PATIENT HAD SEVERE OSTEOLYSIS AND A TIBIAL PLATEAU FRACTURE. THE FRACTURE WAS REPAIRED WITH A SMALL TRABECULAR METAL CONE AND BONE GRAFTS. COMPETITOR PRODUCTS WERE PLACED DURING THE REVISION WHILE THE ATTUNE PATELLA WAS LEFT IN SITU. DOI: (B)(6) 2015. DOR: (B)(6) 2024 (LEFT KNEE).

  Patient problems: Joint Laxity; Osteolysis

  MAUDE report 19637074 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18721512 ↗
• InjuryJul 27, 2023Adverse 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) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17404617 ↗
• InjuryMay 5, 2023Adverse 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) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16876286 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. POLY SWAP WAS DONE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16770353 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERGOES A SUCCESSFUL RIGHT TKA WITH DEPUY SYNTHES IMPLANTS INCLUDING DEPUY CEMENT X 2 AND PATELLA. ON (B)(6) 2020 PATIENT UNDERGOES A CLOSED MANIPULATION UNDER ANESTHESIA FOR STIFFNESS. DOI: (B)(6) 2020. DOR: UNKNOWN. RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 16627261 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO GLOBAL INSTABILITY. SURGEON INCREASED INSERT BY 2MM FOR STABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16271277 ↗
• MalfunctionJan 5, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY VIA TKA. IN THE SURGERY, THE INSERT IN QUESTION COULD NOT BE PLACED PROPERLY. IT FLOATED WITH A GAP OF ABOUT 1MM. THE INSERT WAS REMOVED DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER ONE THAT SIZED UP. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102215 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15968951 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A PRIMARY ATTUNE TKR (PALACOS CEMENT WAS USED) ON THE (B)(6) 2018. PATIENT HAS BEEN EXPERIENCING PAIN AND WAS REVIEWED AT ROYALPERTH HOSPITAL. BONE SCAN WAS HOT, BUT NO INDICATORS FOR OBVIOUS INFECTION. SURGEON COMMENTED THAT IMPLANTS WERE POTENTIALLY OVERSIZED AND THAT THERE COULD BE AN ISSUE WITH FEMORAL ROTATION? AT TIME OF REVISION, SOME FEMORAL OVERHANG WAS NOTED ALONG WITH A TIGHT FLEX ION GAP. THERE WERE NO OBVIOUS SIGNS OF INFECTION AND NONE OF THE PRIMARY COMPONENTS WERE OBVIOUSLY LOOSE OR DAMAGED. THE SURGEON OPTED TO REVISE THE PRIMARY COMPONENTS TO AN ATTUNE REVISION AND DOWNSIZED BOTH THE TIBIA AND FEMUR FROM SIZE 4 COMPONENTS TO SIZE 3 COMPONENTS. DOI: (B)(6) 2018; DOR: (B)(6)2022; RIGHT KNEE.

  Patient problems: Inflammation; Pain

  MAUDE report 14548072 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DECREASED MOTION AND THE EXTENSION WAS BLOCKED. DOI: (B)(6) 2018 ; DOR: (B)(6) 2021 ; RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 13117592 ↗
• MalfunctionSep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO KNEE PAIN, FALL AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. IT WAS REPORTED THAT DURING THE PATIENT'S REVISION PROCEDURE, HER PRIMARY ATTUNE CEMENTED FIXED BEARING TIBIAL TRAY WAS FOUND TO BE LOOSE. UPON FURTHER EXAMINATION, SURGEON NOTED THAT THERE WAS NO BONDING OF CEMENT ON THE UNDERSIDE OF THE TIBIAL TRAY. THE PATIENT'S PRIMARY TIBIAL TRAY AND FIXED BEARING POSTERIOR STABILIZED INSERT WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. SURGEON SAID THAT THE PATIENT FELL APPROXIMATELY ONE YEARS AFTER HER PRIMARY PROCEDURE, INJURING HER OPERATIVE KNEE, BUT DID NOT MAKE SURGEON AWARE THAT SHE HAD FALLEN UNTIL A YEAR LATER. AT THAT TIME, X-RAYS WERE TAKEN, WHICH REVEALED THAT SHE HAD SUSTAINED A PATELLA FRACTURED WHEN SHE FELL. IT HAD SINCE HEALED. SURGEON BELIEVES THE TIBIAL TRAY MAY HAVE BECOME LOOSE WHEN THE PATIENT FELL AND INJURED HER OPERATIVE KNEE. HE ALSO BELIEVES THAT THE DESIGN OF THE UNDERSIDE OF THE TIBIAL TRAY MAY HAVE BEEN A CONTRIBUTING FACTOR AS WELL, SINCE HE HAS HAD TO REVISE MORE THAN A HALF DOZEN PRIMARY ATTUNE CEMENTED FB TIBILA TRAYS THAT HE HAD IMPLANTED DUE TO LOOSENING. A DEPUY SMARTSE

  Patient problems: Fall; Pain

  MAUDE report 12508003 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE PATELLA HAD BEEN RESURFACED AND HAD AN IMPLANT ON IT. IT WAS FOUND TO BE WELL FIXED AND WAS LEFT IN PLACE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11949066 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. AFTER ANESTHESIA WAS ADMINISTERED ROM WAS 10 -120 BUT THERE WAS SOME MID FLEXION INSTABILITY NOTED. POSTERIOR CAPSULAR RELEASE AND MANIPULATION WERE PERFORMED AND A THICKER INSERT WAS PLACED WITH FULL EXTENSION, FLEXION AND STABILITY WERE EXCELLENT. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 11831951 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, LACK OF MOTION AND INSTABILITY. UPON EXAMINATION, MILD INSTABILITY WAS NOTED BUT ROM ONLY SEEMS LIMITED BY PATIENT'S BODY HABITUS. A THICKER INSERT WAS TRIALED, NO ROM LOSS BUT STABILITY WAS ENHANCED. A THICKER INSERT WAS PLACED AFTER CONFIRMATION FROM PATHOLOGY THAT FROZEN SECTION IS NEGATIVE. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11130947 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FLEXION CONTRACTURE AND INSTABILITY WITH HER RIGHT TKA. SURGEON SUSPECTS THIS ISSUE WAS CAUSED BY THE PATIENT'S POOR REHAB, AND HAVING A BMI OF 44. THE SURGEON WANTED TO DO A DEBRIDEMENT AND POLY EXCHANGE, WITH POSSIBLE PATELLA REVISION AND POSSIBLE FEMUR REVISION. THE SURGEON WAS ABLE TO DO A GOOD DEBRIDEMENT AFTER TAKING OUT THE POLY. HE WAS HAPPY BEING ABLE TO GET THE PATIENT IN FULL EXTENSION AND GOOD FLEXION WITH THE POLY TRIAL. THERE WAS NO NEED IN HIS MIND TO REVISION THE PATELLA OR FEMUR, SO HE PUT IN A NEW POLY OF THE SAME THICKNESS AND CLOSED. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10335245 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR REVISED AN ATTUNE FB KNEE FOR INSTABILITY. REVISED FROM SIZE 4 6MM TO 10MM SIZE 4 PS FB INSERT.

  Patient problems: No Code Available

  MAUDE report 10113008 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED ATTUNE TKA TO TREAT SEVERE END-STAGE OSTEOARTHRITIS WITH VARUS OF THE RIGHT KNEE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. RECORDS INDICATE THE PATIENT WAS REVISED DUE TO PAIN, SWELLING, INSTABILITY AND PROGRESSIVE DEFORMITY. PREOPERATIVE RADIOGRAPHIC IMAGING IDENTIFIED COMPLETE LUCENCY AROUND THE TIBIAL TRAY AND WITH TIBIAL VARUS ALIGNMENT AND VARUS COLLAPSE. UPON ENTERING THE KNEE, THE SURGEON IDENTIFIED AND DEBRIDED CAPSULAR SCAR TISSUE AND SYNOVITIS. A COMPLETE CAPSULOTOMY WAS PERFORMED. THE TIBIAL TRAY WAS GROSSLY LOOSE AND WAS COMPLETELY DEBONDED T THE CEMENT TO IMPLANT INTERFACE. UPON REMOVAL TIBIAL TRAY, THE SURGEON DISCOVERED A TIBIAL DEFECT AT THE AREA OF COLLAPSE. THE FEMORAL COMPONENT AND PATELLA WERE WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATIENT RECEIVED DEPUY TIBIAL REVISION PRODUCTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2019; RIGHT KNEE.

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

  MAUDE report 9902650 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE RESECTION OF IMPLANTS WAS PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9847777 ↗

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