ATTUNE 1549-04-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295383048), received between May 17, 2021 and Aug 3, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to insufficient mcl and surgeon put in a hinge.DOI: (b)(6) 2025,DOR: (b)(6) 2026,Affected side: Right knee.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 50119286 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF COMPONENTS OF LEFT KNEE, DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29-JAN-2025, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104, LOT NUMBER ID: J3198U, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151316110, LOT NUMBER ID: J2332W, COMPONENT TYPE: FEMORAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904001, LOT NUMBER ID: J32A89, COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904002, LOT NUMBER ID: J4629Y, COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 150660004, LOT NUMBER ID: 9113354, COMPONENT TYPE: TIBIAL BASE COMPONENT, DEVICE IDENTIFIER: (B)(4), CATALOG NUMBER: 151214030, LOT NUMBER ID: J5202D, COMPONENT TYPE: TIBIAL STEM, DEVICE IDENTIFIER: (B)(4), CATALOG NUMBER: 151302000, LOT NUMBER ID: 8596354, COMPONENT TYPE: FEMORAL STEM OFFSET AD

  Patient problems: Insufficient Information

  MAUDE report 21882034 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED FIRST STAGE RIGHT TOTAL KNEE REVISION FOR A FUNGAL INFECTION OF THE RIGHT KNEE. PT ALREADY HAD IN SITU ATTUNE REVISION IMPLANTS, REQUIRING FULL EXTRACTION OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 15494003 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED FIRST STAGE RIGHT TOTAL KNEE REVISION FOR A FUNGAL INFECTION OF THE RIGHT KNEE. PT ALREADY HAD IN SITU ATTUNE REVISION IMPLANTS, REQUIRING FULL EXTRACTION OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 15493921 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOP BONE FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 14083701 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION DUE TO PAIN AT THE DISTAL TIP OF THE STEM IN THE TIBIA. PATIENT VERY UNHAPPY AND SURGEON PLANNED TO REVISE THE TIBIA COMPONENT, BUT THEN NEEDED TO CHANGE THE FEMORAL COMPONENT ALSO. PATIENT HAS HAD MULTIPLE SURGERIES (B)(6) 2021 THEN AGAIN ON (B)(6) 2021. THIS PC IS THE THIRD REVISION. DOI: UNKNOWN. DOR (1ST): (B)(6) 2021 (REVISION OF COMPETITOR PRODUCTS). DOR (2ND): (B)(6) 2021. DOR (3RD): (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 13869223 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION DUE TO PAIN AT THE DISTAL TIP OF THE STEM IN THE TIBIA. PATIENT VERY UNHAPPY AND SURGEON PLANNED TO REVISE THE TIBIA COMPONENT, BUT THEN NEEDED TO CHANGE THE FEMORAL COMPONENT ALSO. PATIENT HAS HAD MULTIPLE SURGERIES (B)(6) 2021 THEN AGAIN ON (B)(6) 2021. THIS PC IS THE THIRD REVISION. DOI: UNKNOWN. DOR (1ST): (B)(6) 2021 (REVISION OF COMPETITOR PRODUCTS). DOR (2ND): (B)(6) 2021. DOR (3RD): (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 13869135 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SMALL FRACTURE LINE THAT APPEARED IN X-RAYS WAS IN THE BONE.

  Patient problems: Limb Fracture

  MAUDE report 12063547 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SMALL FRACTURE LINE THAT APPEARED IN X-RAYS WAS IN THE BONE.

  Patient problems: Limb Fracture

  MAUDE report 12063546 ↗
• InjuryMay 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO TREAT INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS UTILIZED. PATIENT RECEIVED A TEMPORARY SPACER. DOI: (B)(6) 2019. DOR: (B)(6) 2021; UNKNOWN KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11838978 ↗