ATTUNE 1504-01-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295041337), received between May 6, 2020 and May 5, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Osseointegration Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION. DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 150401104. LOT NUMBER: 3793392. COMPONENT TYPE: FEMORAL.. DESCRIPTION: ATTUNE CR FEM LT SZ 4 POR. CATALOG NUMBER: 150621004. LOT NUMBER: JA04A0460. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 4 POR. CATALOG NUMBER: 151820406. LOT NUMBER: M83K02. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 4 6MM. CATALOG NUMBER: 151810035. LOT NUMBER: 4689234. COMPONENT TYPE: PATELLAR. DESCRIPTION: ATTUNE MEDIAL ANAT PAT 35MM. CATALOG NUMBER: 3322020. LOT NUMBER: 4494872. COMPONENT TYPE: PATELLAR. DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25081086 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED DUE TO INFECTION. STAGE 1 OF 2 KNEE REVISION WAS PERFORMED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24874414 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE FEM POR CR LT SZ 4, ATTUNE FB TIB BASE SZ 5 POR, AND ATUNE CR LT MS INS SZ 4 5 WERE INVOLVED IN A REPORTED EVENT. FOLLOWING A TOTAL KNEE ARTHROPLASTY, THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION, WHICH NECESSITATED IRRIGATION AND DEBRIDEMENT. SUBSEQUENTLY, A REMOVAL SURGERY WAS PERFORMED, AND ALL IMPLANT COMPONENTS WERE EXTRACTED DUE TO UNCONTROLLABLE INFECTION. CEMENT MOLDING WAS COMPLETED SUCCESSFULLY DURING THE REVISION PROCEDURE. THIS PC IS RELATED TO (B)(4), WHICH REPORTS ON THE POSTOPERATIVE INFECTION AND THE DEBRIDEMENT. THIS PC REPORTS ON THE REMOVAL SURGERY AFTER THE DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 24814969 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT PRIMARY SURGERY VIA TKA FOR OA WITH THE PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, SUSPECTED INFECTION OCCURRED ON (B)(6) 2026 AND WAS REPORTED ON (B)(6) 2026. IRRIGATION AND DEBRIDEMENT WERE PERFORMED ON THE SAME DAY. THE PRODUCT WAS REMOVED AND IRRIGATED THOROUGHLY. THERE WAS NO LOOSENESS IN THE OTHER COMPONENTS, SO A NEW PRODUCT OF THE SAME MODEL WAS RE-IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT THIS EVENT IS CONSIDERED NOT RELATED TO THE PRODUCT. NO FURTHER INFORMATION IS AVAILABLE. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24775038 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DEEMED TO BE UNSTABLE. KNEE WAS REVISED TO CONSTRAINED IMPLANT. THERE WAS NO DELAY AND NO HARM TO PATIENT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24083112 ↗
• InjuryJan 13, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SUBSIDENCE. FEMUR AND POLY INSERT WERE EXPLANTED. ALL PIECES WERE REMOVED FROM THE FIELD AND THERE WAS NO HARM DONE TO THE PATIENT NOR DELAY TO THE CASE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060591 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS REFERS TO A REVISION THAT TOOK PLACE IN AN INVESTIGATOR INITIATED CLINICAL STUDY (ATTUNE CEMENTLESS RSA STUDY). ONE PATIENT IN THIS STUDY RECENTLY UNDERWENT A FULL REVISION AT 11 MONTHS POST-OP. THE PATIENT HAD SWELLING AND PAIN UPON PRESENTATION TO THE CLINIC IN SEPTEMBER (UNSCHEDULED VISIT). AN INTERIM CT-RSA WAS PERFORMED WHICH SHOWED NO DISCERNIBLE MIGRATION OF THEIR TIBIAL TRAY, NO OBVIOUS MIGRATION THAT WOULD SUGGEST LOOSENING. THE PATIENT WAS REVISED ON (B)(6) 2025 FOR INFECTION (STAGE 1 OF 2-STAGE PROCEDURE). DR. PERFORMED THE REVISION AND NOTED THE 4 PERIPHERAL PEGS OF THE TRAY WERE SOLIDLY INGROWN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23688557 ↗
• InjuryOct 21, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS REVISED BECAUSE THE PRESSFIT IMPLANT WOULD NOT SIT FLUSH TO BONE. HAD TO REMOVE AND USE CEMENTED FEMUR. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23347748 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENTS RECEIVED FOR EXTENSOR MECHANISM INSUFFICIENCY. ADVERSE EVENT CLASSIFIED AS SERIOUS. DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 15/MAY/2024. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED. GEOGRAPHICAL LOCATION: US. ADDITIONAL EVENT INFORMATION: TREATMENT: OPEN REPAIR OF LEFT TOTAL KNEE ARTHROPLASTY PATELLAR TENDON RUPTURE TO ADDRESS LEFT TOTAL KNEE ARTHROPLASTY, PATELLAR TENDON RUPTURE, ACUTE ON (B)(6) 2024 DOR: NO COMPONENTS WERE REVISED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19948753 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA TENDON RUPTURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024 DATE OF EVENT: (B)(6) 2024 (LEFT KNEE) TREATMENT: PATELLAR TENDON REPAIR DEPUY PRODUCTS USED (NO REVISION COMPLETED):

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19451111 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A CR-TKA SURGERY FOR OA OF THE LEFT KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, WHEN THE PATIENT VISITED THE HOSPITAL DUE TO INSTABILITY OF THE KNEE, LOOSENESS OF THE KNEE JOINT WAS FOUND. THE PATIENT WAS CONSIDERED TO HAVE DEVELOPED LOOSENING OF THE KNEE JOINT DUE TO DYSFUNCTION OF THE POSTERIOR CRUCIATE LIGAMENT, AND A RE-OPERATION WAS SCHEDULED FOR (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2022- INSTABILITY. DOR2: (B)(6) 2022- LOOSENING. LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16052311 ↗
• InjuryOct 19, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY FOR OA VIA TKA WITH THE ATTUNE CS CEMENTLESS IMPLANTS IN QUESTION ABOUT 3 YEARS AGO. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED ON AN UNKNOWN DATE, THAT BOTH THE KNEE FEMORAL IMPLANT (UNK) AND THE TIBIA IMPLANT (UNK) HAS LOOSENING. A REVISION SURGERY WILL BE PERFORMED. THE DATE IS UNDECIDED YET.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15632228 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS TOTAL KNEE REVISION DUE TO SOFT TISSUE IMBALANCE AND VARUS TIBIAL ALIGNMENT. ALL PARTS WERE REMOVED AND REPLACED WITH AN ATTUNE CRS REVISION CONSTRUCT. THE NONCEMENTED FEMUR AND TIBIAL WERE WELL FIXED. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13757749 ↗
• InjurySep 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AFTER PRIMARY KNEE SURGERY ON (B)(6) AND SPLIT OPEN INCISION. SURGEON THEN DID A REVISION I&D, REMOVING IMPLANTS (FEMUR, TIBIA, INSERT), IRRIGATING THE WOUND, AND REPLACING WITH NEW CEMENTED IMPLANTS. PATELLA IMPLANT WAS RETAINED. NO DEFICIENCIES WERE NOTED WITH IMPLANTS. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 12406206 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11172733 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE SURGEON COMMENTED THAT THE SPIN-OUT WHICH OCCURRED 2 WEEKS AFTER THE PRIMARY SURGERY WAS CAUSED BY BAD BALANCE OF EXTENSION AND FLEXING, IT WAS A TECHNICAL ERROR.

  Patient problems: No Code Available

  MAUDE report 10030546 ↗