ATTUNE 1513-16-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10603295043669), received between Oct 5, 2018 and Sep 23, 2026 — classified as 98 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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. 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 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50873408 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50873389 ↗
• MalfunctionJul 8, 2026Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT HAD RT TKA REVISION (B)(6) 2026. DURING PROPER PREPARATION AND SUCCESSFUL TRIALING OF FEMORAL AND TIBIAL IMPLANTS, DURING FEMORAL IMPLANTATION THE IMPLANT WOULD NOT FULLY SEAT. MULTIPLE ATTEMPTS WERE MADE INCLUDING RE-BROACHING AND REAMING OF THE FEMORAL CANAL AND IMPLANT WOULD NOT SIT WHERE FEMORAL TRIALS WERE PREPPED. SURGEON DECIDED TO CONVERT TO A CONE AND STEM CONSTRUCT AND NOT USE THE FEMORAL IMPLANT WITH SLEEVE. THIS LENGTHENED THE CASE ~15-20 MINUTES AS WE NEEDED TO RE-PREP AND BUILD NEW FEMORAL CONSTRUCT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25748771 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE DEVICE RELATED: POSSIBLE PROCEDURE RELATED: POSSIBLE DATE OF EVENT: 15 NOV 2021 DATE OF IMPLANT: (B)(6) 2019 DATE OF REVISION: (B)(6) 2021 DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION, REVISION OF STUDY JOINT, COMPONENTS REMOVED (ATTUNE FEMORAL COMPONENT, ATTUNE TIBIAL INSERT, ATTUNE TIBIAL BASE, ATTUNE TIBIAL STEM, ATTUNE TIBIAL SLEEVE)

  Patient problems: Unspecified Infection

  MAUDE report 25579515 ↗
• InjuryJun 15, 2026Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY, SLEEVE, AND STEM AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION POST REVISION TKA. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTICS AND RESORBABLE ANTIBIOTIC BEADS. SIGNIFICANT BONE LOSS WAS NOTED ON THE TIBIA AS THE INFECTION APPEARED TO HAVE BEEN PRESENT FOR SOME TIME BUT WAS UNTREATED UNTIL PATIENT SHOWED UP IN THE ER. NO DELAY OR PATIENT HARM WAS NOTED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI:(B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Notching; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 25503645 ↗
• MalfunctionJun 2, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING SURGERY, AT THE TIME OF ASSEMBLING THE COMPONENTS, THE THREAD OF THE ROD WAS DAMAGED AND DID NOT SCREW PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365342 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED JOINT INSTABILITY FOLLOWING TOTAL KNEE ARTHROPLASTY REVISION, ATTRIBUTED TO MEDIAL COLLATERAL LIGAMENT (MCL) INSUFFICIENCY. THE SURGEON DETERMINED THAT A HINGE PROSTHESIS WOULD BE REQUIRED TO RESTORE STABILITY. FEMORAL SIDE COMPONENTS WERE REMOVED AND A DISTAL FEMORAL PROSTHESIS WAS PLACED WITHOUT DELAY OR HARM. ALL COMPONENTS WERE WELL FIXED AND PERFORMED AS EXPECTED BUT COULD NOT SUPPORT THE LOSS OF STABILITY POST MCL INSUFFICIENCY. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 24729954 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT HOME AFTER SURGERY AND FELL, RESULTING IN A PERI-PROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23958279 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526846 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526844 ↗
• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DATE OF EVENT: 06 OCT 2025. DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23452642 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND SURGEON ELECTED TO REMOVE IMPLANTS AND FUSE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23369933 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND SURGEON ELECTED TO REMOVE IMPLANTS AND FUSE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23369923 ↗
• InjurySep 10, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE SLEEVE, STEM, AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. REMOVED ALL FEMUR IMPLANTS AND DID NEW. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23016899 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A 5X6 CRS INSERT WAS PUT IN, ON (B)(6) 2022 A 5X5PSRP INSERT WAS PUT IN. PATIENT IS VERY STIFF. PATIENT HAS REQUESTED THE DOCTOR TO TRY ANYTHING TO MAKE KNEE MOVE. DR BELIEVES THE ONLY THING CAN OFFER IS TO CONVERT THIS REV KNEE TO A HINGE. DR. HAS REQUESTED TO HAVE THE ATTUNE REV HINGE SYSTEM SO DR. DOES NOT HAVE TO REMOVE THE WELL-FIXED SLEEVE IN THE FEMUR. ACTIVITY LEVEL - YES. DOI: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE. THIS REPORT CAPTURES THE PATIENT STIFFNESS WHICH WAS OCCURRED AFTER THE 1ST REVISION SURGERY WHILE RELATED COMPLAINT (B)(4) REPORTS THE 1ST REVISION SURGERY WHICH OCCURRED IN (B)(6) 2022.

  Patient problems: Muscular Rigidity

  MAUDE report 23011415 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE. THE PATIENT HAS HAD MILD PAIN SINCE THIS TIME. RECENT ASPIRATION WAS POSITIVE FOR INFECTION WHICH COULD HAVE BEEN PRESENT SINCE THE TIME OF REVISION. A ONE STAGE REVISION WAS PERFORMED AS THE ORGANISM IS SENSITIVE. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED AND THE KNEE WAS WELL BALANCED. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. NEW COMPONENTS, ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. NO DELAYS NOR PATIENT HARM WAS NOTED. SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR REVISION KNEE REPLACEMENTS. CEMENT IS HAND MIXED IN A BOWL. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22792080 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE. THE PATIENT HAS HAD MILD PAIN SINCE THIS TIME. RECENT ASPIRATION WAS POSITIVE FOR INFECTION WHICH COULD HAVE BEEN PRESENT SINCE THE TIME OF REVISION. A ONE STAGE REVISION WAS PERFORMED AS THE ORGANISM IS SENSITIVE. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED AND THE KNEE WAS WELL BALANCED. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. NEW COMPONENTS, ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. NO DELAYS NOR PATIENT HARM WAS NOTED. SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR REVISION KNEE REPLACEMENTS. CEMENT IS HAND MIXED IN A BOWL. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22792012 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POSTOPERATIVELY AND FRACTURED AROUND AND DISTAL TO THE TIBIAL COMPONENT. IMPLANTS WERE REMOVED IN AN EFFORT TO BYPASS THE FRACTURE SITE AND ACHIEVE STABLE FIXATION MORE DISTAL IN THE TIBIA. ALL COMPONENTS HAD PERFORMED AS EXPECTED AND NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. MODULAR FEMORAL COMPONENTS WERE REMOVED TO GAIN EXPOSURE AND WERE EXCHANGED AS THE PATIENT HAD A PRIOR HISTORY OF INFECTION. RESORBABLE ANTIBIOTIC BEADS WERE PLACED AS A PRECAUTION ALTHOUGH EVIDENCE OF PERSISTENT INFECTION WAS NOT PRESENT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 22740742 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DESPITE REPEATED ATTEMPTS TO CURE THE SYSTEMIC INFECTION THIS PATIENT HAD, PATIENT CONTINUED TO SHOW INFECTION AND IT WAS DECIDED TO REMOVE THE IMPLANTS IN HIS RIGHT LEG AND PERFORM AN ABOVE KNEE AMPUTATION. ALL COMPONENTS PERFORMED AS EXPECTED TO THERE WAS NO ALLEGATION AGAINST THE COMPONENTS. THIS SUBMISSION IS BEING MADE AS THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22688966 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22612969 ↗
• InjuryJul 9, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT PATIENT FELL AND HAD A SUBSIDED STEM AND SLEEVE CONSTRUCT FOR PREVIOUS DISTAL FEMUR REPLACEMENT. STEM AND SLEEVE WAS LOOSE AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 22460405 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION AND ALL COMPONENTS WERE REMOVED AND A SPACER WAS MADE WITH NEW COMPONENTS. HIGH DOSE ANTIBIOTICS WERE PLACED ON COMPONENTS ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. HICKMAN CATHETERS WERE ALSO PLACED TO PROVIDE ADDITION ANTIBIOTIC TREATMENT POSTOPERATIVELY. NO PATIENT HARM WAS NOTED AND NO DELAY OCCURRED. -INITIAL PROCEDURE FEMORAL SIDE COMPONENTS WERE REVISED ON (B)(6) 2024 - AN I&D WITH FEMUR AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2025 AND (B)(4) WAS SUBMITTED. THERE WAS A LOOSENING REPORTED AT STEM ON BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22372977 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION FOR INFECTION OF RIGHT REVISION TOTAL KNEE. THE KNEE WAS VERY INFECTED, AND ALL OF THE COMPONENTS CAME OUT WITH MINIMAL EFFORT. NO SPECIFIC COMPONENT WAS GROSSLY LOOSE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22105498 ↗
• InjuryMar 5, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. THE TIBIAL COMPONENTS WERE LOOSE AND THE INTERFACE WAS NON-CEMENTED. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21530140 ↗
• InjuryFeb 19, 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. THE SURGICAL DELAY IS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21410030 ↗