ATTUNE 1517-10-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295056010), received between Dec 7, 2018 and Jun 8, 2026 — classified as 32 injuries, 1 malfunction.

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

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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I & D POLY SWAP DUE TO INFECTION. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25427376 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF RIGHT KNEE PAIN S/P RIGHT TKR. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24958159 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION DUE TO INFECTION. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24753778 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING: 1- WAS THERE A REVISION AFTER THE REPORTED SOFT TISSUE ADHERENCE AND LOSS OF RANGE OF MOTION? OR ANY TREATMENT? YES. 2- WAS THE PREVIOUS REVISION REPORTED "AFTER REVISION TKA WITH ATTUNE REVISION "? IF SO PLEASE PROVIDE THE PC NUMBER. UNKNOWN. 3- KINDLY PROVIDE LOT NUMBER FOR REPORTED PRODUCT. NOT AVAILABLE.

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

  MAUDE report 24251088 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS).

  Patient problems: Unspecified Infection

  MAUDE report 24209601 ↗
• MalfunctionJan 15, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING THE SURGERY, IMPLANT COULD NOT BE IMPLANTED IN PLACE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085465 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025 THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607695 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DETERMINED TO BE UNSTABLE IN FLEXION. SURGEON DECIDED TO UPSIZE POLY INSERT TO ADDRESS THE INSTABILITY. THERE WERE NO COMPLAINTS OR DELAYS. EXPLANT UNAVAILABLE FOR RETURN. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22002193 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED SECOND STAGE ATTUNE REVISION REQUIRING DAIR (DEBRIDEMENT, ANTIBIOTICS AND IMPLANT RETENTION) AND INSERT REPLACEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 21126891 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR POSITIVE TISSUE BIOPSY X2 KNEE SYNOVIUM: DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 15 JAN 2019. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20507083 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 19072162 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND DEHISCED HER WOUND, AND THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND POLY EXCHANGE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 18968774 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: 1. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? - LIGAMENT INSTABILITY 2. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. 3. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. 4. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY. WAS AT ORIGINAL OP, BUT IT DIDN¿T LOOK LIKE IT.

  Patient problems: Joint Laxity

  MAUDE report 18688324 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION ON (B)(6) 2023, DUE TO EXPERIENCING PAIN. THERE WAS NO SURGICAL DELAY. DATE OF ORIGINAL IMPLANT WAS (B)(6) 2022. THIS REPORT IS FOR AN ATTUNE CRS RP INSRT SZ 6 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 17318516 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EXCISION SCAR NEUROMA RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT:(B)(6) 2023. (RIGHT KNEE). TREATMENT: NONE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17191969 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: DIAGNOSTIC INTERVENTION (UNSPECIFIED).

  Patient problems: Pain

  MAUDE report 16762763 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3RD REVISION. ATTUNE REVISION FEMUR LOSENING. PATIENT STATUS/ OUTCOME / CONSEQUENCES. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4): DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: Unspecified Infection

  MAUDE report 16087472 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ACUTE INFECTION. POLY WAS EXCHANGED. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15519525 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR KNEE PAIN AND TMTJ OSTEOARTHRITIS RIGHT FOOT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2022, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY, ORAL MEDICATION, AND INJECTED MEDICATION. PRODUCT DETAILS: CATALOG: 150440206, LOT: J00016A. DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 6 RIGHT CEMENTED.

  Patient problems: Pain

  MAUDE report 13427326 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BROKE HER PATELLA AND INCISION OPENED AND BEGAN DRAINING SO SURGEON ELECTED TO REMOVE IMPLANTS AND PUT IN A STATIC SPACER TO CLEAR THE INFECTION. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 13006708 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PHYSICAL THERAPY NOTES AND PROGRESS NOTES (B)(6) 2021 INDICATE THE PATIENT FELT UNWELL AND LIGHTHEADED MULTIPLE TIMES WITH ONE BRIEF LOSS OF CONSCIOUSNESS DUE TO ORTHOSTATIC HYPOTENSION POST REVISION PROCEDURE ¿ TREATED WITH BOLUS OF 500 ML NORMAL SALINE PER EPISODE.

  Patient problems: Dizziness; Low Blood Pressure/ Hypotension

  MAUDE report 12895755 ↗
• InjuryJul 6, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INSERT SPUN OUT. POLY EXCHANGE WAS PERFORMED. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2019 DOR: (B)(6) 2021 LEFT KNEE

  Patient problems: Insufficient Information

  MAUDE report 12121256 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COULD NOT GET FULL EXTENSION. SO SOME SOFT TISSUE RELEASES AND POLY EXCHANGED WAS DONE. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 11870874 ↗
• InjuryOct 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10656685 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TOTAL KNEE HAD BEEN REVISED ON (B)(6) 2019 FOR INFECTION. PATIENT HAD NEVER FOLLOWED UP AFTER SURGERY AND CAME BACK TO SEE WITH A PAINFUL KNEE. SURGEON WORKED HER UP AND FOUND OUT PATIENT HAD ANOTHER INFECTION AND DECIDED TO REMOVED KNEE IMPLANTS. SURGEON REMOVED ALL THE IMPLANTS WITH NO PROBLEMS AND DID A WASHOUT OF THE KNEE. REPLACED WITH AN ANTIBIOTIC CEMENT SPACER. SURGEON HAD NO DIFFICULTIES REMOVING THE IMPLANTS AND TIME WAS NOT EXTENDED FOR ANY REASON. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 10312190 ↗