ATTUNE 1511-01-203Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295419570), received between Nov 26, 2018 and Jan 23, 2026 — classified as 32 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTS WITH INFECTION POST SPACER. HOWEVER, PATIENT NOW PRESENTS WITH A FUNGAL INFECTION. ALL COMPONENTS PERFORMED AS EXPECTED AND WERE WELL FIXED, HOWEVER HAD TO BE REMOVED TO TREAT THIS NEW FINDING. ALL COMPONENTS WERE SUCCESSFULLY REMOVED, AND AFTER A THOROUGH DEBRIDEMENT, THE BONE WAS PREPARED FOR NEW COMPONENTS. DURING DEBRIDEMENT, A VESSEL WAS PERFORATED DUE TO SCAR TISSUE AND WAS REPAIRED OPERATIVELY. THE SURGEON STATED THIS TO BE A COMMON OCCURRENCE DUE TO THE LOCATION OF DEBRIDEMENT ANATOMICALLY AND WAS EXPECTED AND PREPARED FOR. THIS RESULTED IN A SHORT DELAY WHILE THE REPAIR TOOK PLACE. NEW COMPONENTS WERE PLACED UNEVENTFULLY FOR A NEW SPACER, ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS, ANTIFUNGAL BEADS AND HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2025. DOR: (B)(6) 2026.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 24165469 ↗
• InjuryJan 6, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE LPS FEMUR EXPLANTED DUE TO STEM BREAKING OFF FROM SLEEVE. IT WAS STATED THAT SLEEVE WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23977142 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT HOME AFTER SURGERY AND FELL, RESULTING IN A PERI-PROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23958287 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT UNFORTUNATELY, THE PATIENT WAS STILL INFECTED AND DRAINED SO THE SPACER WAS BEING EXCHANGED IN HOPES TO CLEAR THE INFECTION. NO DELAY NOR PATIENT HARM WAS NOTED.

  Patient problems: Unspecified Infection

  MAUDE report 23592613 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE EXTRACTED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23404446 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22853170 ↗
• InjuryJan 22, 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. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21209068 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20589017 ↗
• InjuryMay 3, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH PAIN IN FEMUR. SERIAL X-RAYS SHOW SUBSIDENCE OF FEMORAL SLEEVE AND STEM AFTER FAILURE OF INGROWTH. PATIENT REVISED UNEVENTFULLY TO A CEMENTED STEM AFTER FAILURE OF A CEMENTLESS DEVICE. THERE WAS LOOSENING OF FEMORAL SLEEVE AND STEM AT THE NON CEMENTED INTERFACE. NO PATIENT HARM OCCURRED OF DELAY WAS EXPERIENCED. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19237335 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FELL AND RUPTURED THE PATELLAR TENDON. TO APPROPRIATELY REPAIR, SURGEON CHOSE TO SHORTEN THE FEMORAL CONSTRUCT BUT TO DO SO HAD TO REMOVE WELL FIXED COMPONENTS. STEM AND SLEEVE HAD BEEN PLACED ON (B)(6) 2023 AS PART OF A SPACER AND WAS RETAINED WHEN CONVERTED TO A DISTAL FEMUR ON THE DATE LISTED ON THE FORM. NO DELAY WAS EXPERIENCED AND NO HARM OCCURRED. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19153277 ↗
• InjuryMar 26, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO FEMORAL LOOSENING AT THE UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18977636 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: 1. THE PATIENT FELL AND NEEDED LARGER COMPONENTS. 2. NO REPORTED SURGICAL DELAYS.

  Patient problems: Fall; Pain

  MAUDE report 18893617 ↗
• InjuryJul 25, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENT IN OFFICE WITH THIGH PAIN. SERIAL X-RAYS SHOW LUCENCY AROUND STEM AND SUBSIDENCE OF SLEEVE LEADING SURGEON TO BELIEVE THAT THE STEM SLEEVE DID NOT ACHIEVE STABLE INGROWTH. SLEEVE IS FOUND TO HAVE ONLY ACHIEVED FIBROUS INGROWTH AND IS REMOVED. A CEMENTED BOWED STEM IS PLACED UNEVENTFULLY AFTER CLEARING FIBROUS TISSUE. NO PATIENT HARM OCCURRED. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Inadequate Osseointegration; Pain

  MAUDE report 17391231 ↗
• 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)(6) DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(6) DEVICE PROPERTY OF? NONE. DEVICE I

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17058070 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION, ATTUNE SPACER PUT IN ITS PLACE. IMPLANTS RETAINED BY HOSPITAL. NO OTHER CONSEQUENCES TO PATIENT. PRIMARY SURGERY DATE IS UNKNOWN, FIRST REVISION SURGERY DATE (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15874022 ↗
• InjuryNov 15, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO FEMORAL SLEEVE AND TIBIAL SLEEVE BEING LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15796484 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE NEED TO SPEAK TO SOMEONE WITH THE DEPUY DIVISION. HE HAS A FEW QUESTIONS IF THERE IS A RECALL WITH THE PRODUCT. HE HAD SOME PROBLEMS WITH THE PRODUCT THAT WAS ON HIS LEFT LEG AND IT WAS SUPPOSED TO LAST 10-15 YEARS BUT IT ONLY LASTED FOR 2 YEARS(SCN). DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 15264900 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR INFECTION, PATIENT HAD BEEN REVISED FOR INFECTION IN THE PAST.

  Patient problems: Unspecified Infection

  MAUDE report 15191366 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. SURGEON CONVERTED FEMUR TO HINGE FEMUR. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13900503 ↗
• 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 13006729 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS LINKED TO (B)(4) WHICH REPORTED ON THE NON-DEPUY PRIMARY SURGERY. PATIENT UNDERWENT REVISION KNEE SURGERY ON (B)(6) 2020 WHERE AN ATTUNE REVISION SYSTEM WAS UTILISED (DR (B)(6), (B)(6) HOSPITAL). DEPUY CEMENT NOT UTILISED. PATIENT INITIALLY DID WELL BUT OVER TIME HAS HAD PROGRESSIVE RESTRICTION TO RANGE OF MOTION. PATIENT HAS PRESENTED WITH A STIFF KNEE. APPROXIMATELY 25 DEGREES OF EXTENSION TO 80 DEGREES FLEXION A DECISION WAS MADE TO OPEN THE KNEE, REMOVE AS MUCH SCAR TISSUE AS POSSIBLE AND EXCHANGE THE 8MM POLY INSERT TO A 6MM POLY INSERT. ALL COMPONENTS WERE WELL FIXED THE RANGE OF MOTION WAS IMPROVED TO APPROXIMATELY 5 DEGREES TO 110 DEGREES. DOI: UNKNOWN (NON-DEPUY PRODUCTS), DOR (1ST): (B)(6) 2020, DOR (2ND): (B)(6) 2021.

  Patient problems: Muscular Rigidity

  MAUDE report 12933449 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT "PAIN WITH LEVEL WALKING IS 8".

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12189490 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOW BACK PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE ADVERSE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: RADIATION.

  Patient problems: Pain

  MAUDE report 11744517 ↗
• MalfunctionFeb 26, 2021Inadequacy of Device Shape and/or Size; Difficult to Advance; Inadequacy of Device Shape and/or Size; Difficult to Advance

  ADDITIONAL INFORMATION WAS RECEIVED ON 02/23/2021 STATING THAT THIS WAS A CONSISTENT PROBLEM. IT OCCURS ABOUT 4 OUT OF 5 CASES. IF IT DOESN'T OCCUR, THE FEMUR OR TIBIA CRACKS, WHICH THEN ALLOWS THE CONSTRUCT TO SEAT. THIS HAS BEEN DOCUMENTED EVERY TIME AND SHOULD NOT BE A SURPRISE TO ANYONE. ADDITIONAL INFORMATION WAS RECEIVED ON 03/01/2021 STATING THAT THE SIGMA COMPONENTS WERE THE TEMPORARY SPACER PARTS.

  Patient problems: Insufficient Information

  MAUDE report 11388392 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. REMOVAL OF IMPLANTS WAS PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10507309 ↗