ATTUNE 1513-14-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295043614), received between Mar 14, 2019 and May 15, 2026 — classified as 53 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 55 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD WOUND BREAKDOWN POST MULTIPLE REVISION TKA LEADING TO POTENTIAL CONTAMINATION OF PROSTHESES. SURGEON CHOSE TO REMOVAL ALL WELL FIXED AND WELL FUNCTIONING COMPONENTS AND PLACE A STATIC SPACER FASHIONED WITH LPS COMPONENTS WITHOUT DELAY NOR PATIENT HARM. A GASTROC FLAP WAS PERFORMED BY THE PLASTIC SURGEON POST SPACER PLACEMENT IN HOPES OF HEALING THIS WOUND. THIS PATIENT HAS HAD MULTIPLE SURGERIES SINCE THIS DATE TO ADDRESS COMPLICATIONS WITH IMPLANTS BEING EXCHANGED. CEMENT THAT WAS USED WAS DEPUY 2 WITH GENT. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25188227 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WOUND BREAKDOWN POST MULTIPLE REVISION TKA LEADING TO POTENTIAL CONTAMINATION OF THEIR PROSTHESES. THE SURGEON CHOSE TO REMOVAL ALL WELL FIXED AND WELL FUNCTIONING COMPONENTS AND PLACE A STATIC SPACER FASHIONED WITH LPS COMPONENTS WITHOUT DELAY NOR PATIENT HARM. A GASTROC FLAP WAS PERFORMED BY THE PLASTIC SURGEON POST SPACER PLACEMENT IN HOPES OF HEALING THIS WOUND. THIS PATIENT HAS HAD MULTIPLE SURGERIES SINCE THIS DATE TO ADDRESS COMPLICATIONS WITH IMPLANTS BEING EXCHANGED. THE DATES WERE AND THE DER NUMBERS ARE LISTED (B)(6). DOI: (B)(6), 2026 DOR: (B)(6), 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25187336 ↗
• InjuryApr 20, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE WHEN WALKING AND REQUIRED REVISION SURGERY DUE TO LOOSENING OF IMPLANTS. THE REVISION PROCEDURE WAS PERFORMED TO ADDRESS PAIN AND IMPLANT LOOSENING AT AN UNKNOWN INTERFACE, AND ALL AFFECTED IMPLANTS WERE EXPLANTED AND DISCARDED. PATIENT HAD 3 PREVIOUS REVISIONS ON THIS KNEE.

  Patient problems: Pain

  MAUDE report 24927624 ↗
• InjuryApr 15, 2026Loss of or Failure to Bond; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED LOOSE TIBIAL IMPLANT. NO PATIENT COMPLICATIONS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24884568 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED FOR INFECTION. SURGEON REMOVED PROSTHESIS PUT IN TEMPORARY SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24485135 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN LPS DISTAL FEMORAL REPLACEMENT REVISION TKA PLACED ON (B)(6) 2025. HE PRESENTED WITH A DRAINING KNEE AND WAS BROUGHT TO THE OR FOR A ONE STAGE REVISION UTILIZING A DUAL SET UP. ALL COMPONENTS WERE FUNCTIONING AS EXPECTED SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. CEMENT WAS DEPUY 2 WITH GENT, HOWEVER IS HOSPITAL OWNED SO NO QTY OR LOT INFORMATION IS AVAILABLE. BOTH TIBIAL AND PATELLAR COMPONENTS WERE WELL FIXED VIA CEMENT SO NO ALLEGATION IS MADE AGAINST THE CEMENT. WHILE WELL FIXED, NO INGROWTH WAS FOUND ON EITHER SLEEVE, FURTHER CONFIRMING INFECTION. A THOROUGH IRRIGATION AND DEBRIDEMENT WAS PERFORMED AFTER ALL COMPONENTS WERE REMOVED. NEW COMPONENTS WERE PREPARED FOR. NEW COMPONENTS WERE OPENED ON A "CLEAN" TABLE AND IMPLANTED AFTER NEW DRAPES AND STAFF CHANGING INTO "CLEAN" GOWNS AND GLOVES WAS COMPLETED. ALL NEW COMPONENTS WERE PLACED ALONG WITH RESORBABLE ANTIBIOTIC BEADS AND ANTIBIOTIC CEMENT. NO DELAY NOR PATIENT HARM WAS NOTED. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 24266998 ↗
• InjuryJan 5, 2026Loss of or Failure to Bond; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF AN ATTUNE DUE TO LOOSE FEMORAL AND TIBIAL COMPONENTS. THE SURGEON NOTED FIBROUS TISSUE UP THE FEMORAL CANAL AROUND THE FEMORAL STEM CAUSING LOOSENING. THE TIBIAL COMPONENT WAS LOOSE AS IT APPEARED THAT THE SURGEON HAD CEMENTED IN THE CEMENTLESS TIBIAL SLEEVE. RESULTING IN NO BONE INGROWTH. THE PATELLA COMPONENT WAS RETAINED FROM PREVIOUS PRIMARY TKR. THE LOOSENING WAS BETWEEN THE IMPLANT AND BONE INTERFACES. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Fibrosis; Inadequate Osseointegration

  MAUDE report 23958190 ↗
• 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 23452533 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS END-STEM PAIN ON TIBIA. SO IT WAS REVISED TO SHORTER THE STEM. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23095462 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT IMPLANT REMOVAL DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22730694 ↗
• InjuryJul 2, 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. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22387120 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INFECTION IN KNEE AND WAS REVISED DUE TO THAT. THE SURGEON REMOVED ALL COMPONENTS AND PLACED ABX SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22025175 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN NOT RESOLVING AS EXPECTED IN REVISION KNEE/PLAN TO PERFORM REVISION: DEVICE (RELATEDNESS): DEFINITELY NOT, PROCEDURE (RELATEDNESS): PROBABLY, DATE OF EVENT: 03 JUL 2020, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: (B)(6) 2022, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION OF THE STUDY KNEE TIBIAL TRAY, TIBIAL STEM, AND TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 21984457 ↗
• InjuryFeb 19, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIA LOOSENING ON THE BONE IMPLANT AND BONE/CEMENT INTERFACE. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21414542 ↗
• InjuryOct 21, 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. B. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS -NO.

  Patient problems: Unspecified Infection

  MAUDE report 20492413 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STEM PAIN FROM PRIOR REVISION. TIBIA WAS REVISED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 20462600 ↗
• InjuryOct 8, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ATTUNE REVISION STEM BENT OFF OF SLEEVE WAS POTTED IN BOW OF THE FEMUR. THE FEMUR WAS REVISED. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20397933 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION REPORTED FOR FEMORAL LOOSENING. RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20320935 ↗
• InjuryApr 8, 2024Adverse 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. THERE WAS NO DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19058637 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE REPLACEMENT IN 2022 DUE TO INFECTION. THE PATIENT PRESENTED TO THE CLINIC AGAIN IN FALL 2023. A FURTHER REVISION DUE TO AN INFECTION IS PLANNED FOR (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 18413944 ↗
• InjuryDec 20, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD DISTAL FEMORAL REPLACEMENT ON (B)(6), 2023. PATIENT WAS REVISED TO A NEW DISTAL FEMORAL REPLACEMENT. IT APPEARED THAT THE ATTUNE REVISION FEMORAL SLEEVE AND MAYBE THE STEM MAY BE LOOSE. PATIENT WAS REVISED AND WENT UP ON FEMORAL SLEEVE SIZE. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18362732 ↗
• InjuryOct 17, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM AND ATTUNE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. PATIENT CAME IN TO ER WITH DISLOCATED DEPUY LPS DISTAL FEMORAL REPLACEMENT. WHILE OPENING TO REVISE, IT WAS ALSO APPARENT THAT THE KNEE WAS INFECTED. ALL IMPLANTS WERE REMOVED EXCEPT THE TIBIA BASEPLATE, TIBIAL SLEEVE AND STEM. ANTIBIOTIC SPACER IMPLANTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 17948332 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION FEMORAL COMPONENT, INCLUDING SLEEVE AND STEM FOR STIFFNESS. PATIENT UNDERWENT REVISION ATTUNE APPROX 3 YEARS AGO (EXACT DATE UNKNOWN). PRESENTED WITH STIFFNESS, FIXED FLEXION AT 25-30 DEGREES. FEMORAL COMPONENTS REMOVED AND SROM ROTATING PLATFORM HINGE FEMORAL COMPONENT WITH ATTUNE CROSS OVER BEARING INSERTED. SURGEON ABLE TO GET FULL EXTENSION ON THE TABLE. TIBIAL COMPONENTS NOT REVISED. TRYING TO SOURCE COMPONENT SIZES AND LOT NUMBERS FROM CUSTOMER SERVICES. IF OTHER, DESCRIBE: REVISION OF ATTUNE REVISION FEMORAL COMPONENT TO SROM HINGE., WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES? PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY? NO, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVIC

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17058446 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN. SURGEON REVISED STEM TO A SHORTER STEM. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16777297 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION KNEE ARTHROPLASTY IN (B)(6) 2019. SURGEON REMOVED FEMUR AND SLEEVE AND REPLACED WITH A LARGER SIZE SLEEVE. SURGEON SAID THAT THE PATIENT WAS COMPLAINING OF PAIN. FEMUR AND SLEEVE WERE WELL FIXED AND TOOK TIME TO REMOVE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16487160 ↗