ATTUNE 1511-01-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295419563), received between May 3, 2019 and Sep 30, 2026 — classified as 74 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (16 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 77 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Osseointegration Problem

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 50951588 ↗
• 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 50119278 ↗
• 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) 2026 (B)(6) , (B)(6) 2026 (B)(6), (B)(6) 2026 (B)(6). DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 25187411 ↗
• 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; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 24267043 ↗
• 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. AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 24163950 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AS ASPIRATION POST SPACER AND WAS FOUND TO NOW BE GROWING YEAST. SURGEON CHOSE TO REPLACE THE EXISTING SPACER AND TREAT FOR YEAST. ALL COMPONENTS WERE FOUND TO BE INGROWN, DESPITE THE PRESENCE OF YEAST. ALL WERE REMOVED AND NEW COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT AND RESORBABLE BEADS TO ADDRESS YEAST. UPON INSERTING THE NEW COMPONENTS ON THE FEMORAL SIDE, A FRACTURE WAS NOTED, DESPITE A CABLE BEING PLACED PRIOR TO PREP AND INSERTION. COMPONENTS WERE EXCHANGED AND A LONGER STEM AND AN ADDITIONAL CABLE WAS PLACED TO ADDRESS THE FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE. THIS REPORT IS RELATED (B)(4), WHICH CAPTURES THE FRACTURE DURING INSERTION OF NEW DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 23697825 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23526888 ↗
• InjuryOct 21, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT'S DISTAL FEMORAL COMPONENT, SLEEVE, AND STEM SUBSIDED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23351125 ↗
• InjuryOct 15, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO FEMORAL COMPONENTS WERE REMOVED DUE TO ASEPTIC LOOSENING. IT WAS STATED THAT THE FEMUR & SLEEVE WERE LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23302214 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES, SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828047 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY, A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI. FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM; THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TOURNIQUET WAS REMOVED AND THE LEG MOVED POST OP. THE PATIENT WAS TRANSFERRED TO HAVE PLATING COMPLETED TO REPAIR THIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 22703136 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DESPITE REPEATED ATTEMPTS TO CURE THE SYSTEMIC INFECTION THIS PATIENT HAD, PATIENT CONTINUED TO SHOW INFECTION AND IT WAS DECIDED TO REMOVE THE IMPLANTS IN HIS RIGHT LEG AND PERFORM AN ABOVE KNEE AMPUTATION. ALL COMPONENTS PERFORMED AS EXPECTED TO THERE WAS NO ALLEGATION AGAINST THE COMPONENTS. THIS SUBMISSION IS BEING MADE AS THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 22688985 ↗
• InjuryJul 9, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT PATIENT FELL AND HAD A SUBSIDED STEM AND SLEEVE CONSTRUCT FOR PREVIOUS DISTAL FEMUR REPLACEMENT. STEM AND SLEEVE WAS LOOSE AT NON-CEMENTED INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 22460415 ↗
• 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 22387112 ↗
• InjuryJun 17, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED A REVISION OF A LEFT KNEE OCCURRED ON (B)(6) 2025 WHERE AN ATTUNE IMPLANT WAS EXPLANTED. THE IMPLANTS BOTH SIDE WERE LOOSE AND THE TIBIAL STEM HAD MIGRATED OUTSIDE OF THE TIBIAL BONE. ORIGINAL IMPLANT WAS DONE IN 2021. THE ATTUNE REVISION IMPLANTS REMOVED HAD NO BONE ON GROWTH ON THE FEMORAL METAPHYSEAL SLEEVE AND LIMITED ON THE TIBIAL METAPHYSEAL SLEEVE. THE POLY HAD TO BE SPLIT FOR REMOVAL PURPOSES BUT WAS INTACT AT TIME OF REVISION. THE SURGEON STATED THERE WAS NO INFECTION PRESENT. SURGEON SUSPECTS REACTION TO THE METAL. THE PATIENT WAS REVISED TO ANOTHER COMPANY'S IMPLANTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22236003 ↗
• InjuryJun 11, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT HAD A FALL AND FEMORAL SLEEVE SUBSIDED A BIT. REVISION WAS PERFORMED. THE TIBIA WAS NOT REVISED, AND THERE WAS NO ALLEGATION IN RELATION TO THE STEM, THERE WAS NO INSTABILITY ATTRIBUTED TO THE FALL. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 22184128 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION FOR INFECTION OF RIGHT REVISION TOTAL KNEE. THE KNEE WAS VERY INFECTED, AND ALL OF THE COMPONENTS CAME OUT WITH MINIMAL EFFORT. NO SPECIFIC COMPONENT WAS GROSSLY LOOSE. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22105337 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REVISION ON A DISTAL FEMUR DUE TO PATELLA INSTABILITY. PATELLA WAS NATURAL AND WAS NOT RESURFACED OR REVISED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22071131 ↗
• InjuryMay 13, 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. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22011888 ↗
• InjuryApr 24, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON REVISED THE PATIENT'S DISTAL FEMORAL REPLACEMENT BECAUSE THE ATTUNE 30MM FEMORAL SLEEVE WAS LOOSE. THERE WAS ATTUNE REVISION 30MM FULLY POROUS FEMORAL SLEEVE LOOSENING AT THE NON-CEMENTED INTERFACE. THERE WAS NO SURGICAL DELAY RELATED TO THE EVENT. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21900226 ↗
• InjuryApr 21, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT SURGEON REVISED THE PATIENT¿S DISTAL FEMORAL REPLACEMENT BECAUSE THE ATTUNE 30MM FEMORAL SLEEVE WAS LOOSE. REVISED TO ATTUNE FULLY POROUS 30MM FEMORAL SLEEVE AT NON-CEMENTED INTERFACE. THERE WERE NO OTHER ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21871966 ↗
• InjuryFeb 19, 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. THE SURGICAL DELAY IS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21410032 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HAD A REVISION KNEE DONE IN APRIL 2024. IT WAS DISLOCATED AND NEEDED TO BE REVISED FOR STABILITY. THE PATIENT HAD AN ATTUNE REVISION FEMUR WITH SLEEVE AND STEM. THE TIBIA WAS AN ATTUNE REVISION ROTATING PLATFORM WITH SLEEVE AND STEM. THE FEMORAL COMPONENT, FEMORAL SLEEVE AND STEM WERE EXTRACTED AND THE PATIENT WAS CONVERTED TO AN SROM HINGE FEMUR WITH UNIVERSAL SLEEVE AND UNIVERSAL STEM, ALONG WITH A BRIDGING BEARING. THE ATTUNE REVISION TIBIAL TRAY/SLEEVE/STEM CONSTRUCT WAS NOT REVISED. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21328442 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID:(B)(6). STUDY NO:(B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR POSITIVE TISSUE BIOPSY X2 KNEE SYNOVIUM. DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT , PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 15 JAN 2019, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20507150 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN IMPLANTING THE FEMORAL COMPONENT WITH SLEEVE AND STEM, SMALL FRACTURE OCCURRED IN FEMUR REQUIRING CABLES, WHICH RESULTED IN TEN MINUTES OF SURGICAL DELAY.

  Patient problems: Limb Fracture

  MAUDE report 20360932 ↗