ATTUNE 1504-10-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 10603295041627), received between Jul 26, 2017 and Sep 24, 2026 — classified as 112 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (24 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that surgeon revised for instability. No patient complications. No further information.DOI-UnknownDOR-(b)(6) 2026Affected side-Left knee

  Patient problems: Joint Laxity

  MAUDE report 50878007 ↗
• InjuryMar 2, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF START UP PAIN. X-RAYS SHOWED LOOSE TIBIA AND FEMUR. IT WAS STATED THAT FEMUR & TIBIA WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT/IMPLANT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24482173 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL SURGERY FOR INFECTION ASSOCIATED WITH THE PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY, AND THE SURGEON INDICATED THAT THE CAUSE OF THE INFECTION WAS UNRELATED TO THE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 24306532 ↗
• InjuryJan 7, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. TIBIA SUBSIDED. PATIENT OUTCOME IS REPORTED AS GOOD. DOI- (B)(6) 2020. DOR- (B)(6) 2025. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23993031 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANTED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 22787173 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL OF FEMUR, TIBIA AND INSERT DUE TO PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21975516 ↗
• InjuryApr 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 CONTINUED INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21774348 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. THE IMPLANTS WERE REMOVED USING OSTEOTOMES AND MILD IMPACTION FORCE. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21173727 ↗
• InjuryJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO FELL. PATIENT DISLOCATED PS FEMUR. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 21113797 ↗
• InjuryOct 24, 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 20522120 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THERE WAS NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20521969 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR KNEE STIFFNESS: DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: DEFINITELY. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 16 SEP 2024. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: PHYSICAL THERAPY. DEPUY SYNTHES PRODUCT USED: COMPONENT TYPE: FEMORAL COMPONENT. CATALOG NUMBER: 150410105. LOT NUMBER ID: 3851774. DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL BASE COMPONENT CATALOG NUMBER: 150680006 LOT NUMBER ID: 4022166 DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL STEM. CATALOG NUMBER: 151310110. LOT NUMBER ID: J8383W. DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL SLEEVE. CATALOG NUMBER: 151111201. LOT NUMBER ID: J94Z36. DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL INSERT COMPONENT: CATALOG NUMBER: 151650505. LOT NUMBER ID: 3787761. UDI: (B)(4). COMPONENT TYPE: CEMENT: CATALOG NUMBER: 3003940002. LOT NUMBER ID: AX42AK0B03. DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Muscular Rigidity

  MAUDE report 20407068 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC DISTAL FEMUR FRACTURE. DOI: (B)(6) 2024. DOR:(B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 19731827 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO DELAY WAS IDENTIFIED. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO INSTABILITY WAS REPORTED DUE TO THE POLYETHYLENE WEAR. C. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. D. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. E. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO.

  Patient problems: Fibrosis; Joint Laxity

  MAUDE report 19164910 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TWISTED AND FELL CLIMBING STAIRS FRACTURING THE DISTAL FEMUR. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 19127734 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18947238 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO SURGICAL DELAY. THE LOT NUMBER OF THE ORIGINAL FEMORAL COMPONENT WAS D23040563. ALSO, DEPUY CEMENT WAS USED IN THE ORIGINAL SURGERY HOWEVER, THE LOT NUMBER IS UNAVAILABLE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 18789383 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE LOOSENING INTERFACE WAS TIBIA FROM CEMENT. THE CEMENT USED IS ALSO UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18606786 ↗
• MalfunctionJan 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18599974 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS CONCERN ABOUT ATTUNE DEPUY KNEE REPLACEMENT. THE PATIENT HAS BEEN EXPERIENCING PAIN, SWELLING, EFFUSION, AND THE FEELING LIKE HER KNEE IS GIVING OUT. THE PATIENT IS MEETING WITH A SURGEON TO DISCUSS POTENTIAL REVISION. DOI: (B)(6) 2018 AFFECTED SIDE: LEFT KNEE

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 18541753 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18075298 ↗
• MalfunctionOct 13, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PRODUCT IN QUESTION WAS PLANNED TO BE USED IN THE SURGERY VIA TKA FOR OA ON KNEE. IN THE SURGERY, THE FOREIGN SUBSTANCE WAS FOUND BY THE SURGEON. SINCE THERE WAS A SPARE, IT WAS OPENED AND USED INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929635 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT REVISION OF A PRIMARY ATTUNE PATELLA ON (B)(6) 2023 BY THE REVISING SURGEON AT (B)(6) HOSPITAL. THE PATIENT'S PRIMARY LEFT KNEE SURGERY WAS DONE AT THE SAME HOSPITAL ON (B)(6) 2017 BY THE PRIMARY SURGEON. THE PATIENT COMPLAINED OF KNEE PAIN. THE X-RAYS SHOW THE PATELLA TRACKING IMPROPERLY. UPON REVISION SURGERY, THE WORN PATELLA WAS REMOVED AND A NEW ONE IMPLANTED AS WELL AS PATELLA TENDON RELEASE. THE ORIGINAL PATELLA IMPLANT WAS WELL FIXED. THE PATELLA IMPLANT WHICH WAS REMOVED, ALONG WITH THE CEMENT TYPE THAT WAS USED FOR THE PRIMARY SURGERY WERE ATTACHED. SMARTSET CEMENT WAS USED. THERE WAS NO TIME DELAY IN THIS SURGERY. THE PATELLA IMPLANT FAILED DUE TO PATELLA TRACKING ISSUE, NOT DUE TO A FAULTY IMPLANT. CURRENT X-RAYS, ORIGINAL IMPLANT LOG FROM 2017, AND PICTURE OF THE IMPLANT WERE ATTACHED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscle/Tendon Damage; Pain

  MAUDE report 17719087 ↗
• InjuryJun 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PAINFUL KNEE IMPLANTS WERE LOOSE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17215909 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT KNEE.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 17018840 ↗