ATTUNE 1511-06-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295503408), received between Aug 2, 2021 and Jun 19, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Fracture

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL SLEEVE AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT THE STEM BOLT BROKE AT THE STEM SLEEVE JUNCTION. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25561700 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HEMATOMA POST REVISION TKA. SURGEON PERFORMED AN EVACUATION OF HEMATOMA WITH A THOROUGH I&D AND COMPONENT EXCHANGE. ALL COMPONENTS WERE WELL FUNCTIONING SO NO ALLEGATION WAS MADE AGAINST ANY COMPONENT, HOWEVER CHOSE TO EXCHANGE MODULAR COMPONENTS AS THE RISK FOR INFECTION IS ELEVATED IN THIS CIRCUMSTANCE. CABLE WAS ALSO REMOVED AS IT COULD HARBOR BACTERIA IF INFECTION IS FOUND TO BE PRESENT ON CULTURES. CULTURES WERE TAKEN AS A PRECAUTION AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED. NO DELAY OR PATIENT HARM WAS NOTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 24733275 ↗
• 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 24267090 ↗
• 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 23592609 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND SURGEON ELECTED TO REMOVE IMPLANTS AND FUSE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23369926 ↗
• 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 23351128 ↗
• InjurySep 25, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON HAS HAD MULTIPLE FAIL TO INGROW WHEN UTILIZING FOR DISTAL FEMORAL REPLACEMENTS, SPECIFICALLY IN FEMALE PATIENTS SINCE TRANSITIONING FROM UNIVERSAL SLEEVES AND STEM FROM OUR PREVIOUS SYSTEM, TO ATTUNE STEMS AND FEMORAL SLEEVES. DUE TO REPEATED FAILURES, HE HAS TRANSITIONED BACK TO THE PREVIOUS VERSION FOR THIS TYPE OF PROCEDURE. HE USED THE PREVIOUS VERSION FOR MULTIPLE YEARS IN HIGH VOLUME WITH RARE FAILURES. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE : LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20302010 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN TO DRAIN AGAIN POST ANTIBIOTIC SPACER FASHIONED WITH LPS COMPONENTS. ALL COMPONENTS WERE REMOVED. DURING DISSECTION AND REMOVAL, A VASCULAR INJURY OCCURRED. THE VASCULAR TEAM CAME IN TO REPAIR THE VESSELS. A NEW SPACER UTILIZING LPS COMPONENTS WAS PLACED AFTER A THOROUGH DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS A DELAY IN THE PROCEDURE AND HARM DID OCCUR BUT THERE WAS NO MENTION OF ALLEGATION AGAINST ANY DEPUY COMPONENTS CAUSING SAID INJURY. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Perforation of Vessels

  MAUDE report 20239583 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND LIMITED MOTION. OPERATIVELY, SIGNIFICANT SCARRING WAS NOTED WHICH WAS RELEASED ALONG WITH PATELLAR IMPINGEMENT. THE PATELLAR COMPONENT WAS REVISED TO A SMALLER PROSTHESIS AND SHIFTED MORE PROXIMALLY WHICH LED TO BETTER RANGE OF MOTION ONCE ALL SCARRING WAS ADDRESSED. THERE WAS NO PATIENT HARM OCCURRED AND NO DELAYS WERE EXPERIENCED. EXCHANGED COMPONENTS ARE LISTED. ALL COMPONENTS WERE WELL FIXED. FROZEN SECTIONS TAKEN OPERATIVELY SHOWED NO SIGNS OF INFECTION. THE PATELLA WAS PLACED ON (B)(6) 2023. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain

  MAUDE report 19584315 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A FALL 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 19153160 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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: Unspecified Infection

  MAUDE report 17948331 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PATELLA THAT WAS NOT TRACKING AND WAS RIDING LATERALLY OUTSIDE THE DISTAL FEMORAL REPLACEMENT. SURGEON CHOSE TO SHORTEN THE CONSTRUCT BY REDUCING THE INSERT THICKNESS AND PERFORMED AN EXTENSIVE LATERAL RELEASE. THE PATELLA HAD PREVIOUSLY NOT BEEN RESURFACED AND SURGEON CHOSE TO PLACE A PATELLAR IMPLANT. TRACKING WAS RESTORED AND A MEDIAL REPAIR TO THE RETINACULUM WAS PERFORMED. NO PATIENT HARM OCCURRED NOR DEFICIENCY STATED. COMPONENTS WERE EXCHANGED OR REPLACED DUE TO REPOSITIONING OF COMPONENTS TO ENHANCE PATELLAR TRACKING. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17907118 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: PLEASE CONFIRM THE REASON FOR THE CABLE WITH A CABLE SLEEVE WAS IMPLANTED. WAS THERE A FRACTURE THAT OCCURRED DURING THE IMPLANTATION OF THE IPS FEMORAL CONSTRUCT? = THE CABLE IS USED TO PREVENT A FRACTURE FROM OCCURRING. IT IS USED IN 100% OF THE SURGEONS' CASES TO AVOID CATASTROPHIC FAILURE FROM BROACHING, IMPLANTATION, OR LOADING OF THE CONSTRUCT WHILE INGROWTH TAKES PLACE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 17549476 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ADMITTED THROUGH THE ER WITH SUSPECTED INFECTION. ASPIRATION CONFIRMED THE INFECTION. ALL COMPONENTS WERE REMOVED, A THOROUGH DEBRIDEMENT WAS PERFORMED, AND A SPACER AND RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. TIBIAL COMPONENTS WERE PLACED SOMEWHERE ELSE AT AN UNKNOWN TIME AND LOCATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17119050 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? --> NO B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? --> NO C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? --> NO D. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? --> JOINT LINE WAS SET BY PREVIOUS SURGERY. E. PLEASE CLARIFY IF THE PATIENT'S PATELLA HAD ALREADY RESURFACED PRIOR TO THIS REVISION, AND IF SO, WAS THE PATELLA PRODUCT A DEPUY PATELLA IMPLANT? IF IT IS, IT WILL NEED TO BE ADDRESSED FOR JOINT INSTABILITY FOR THE PATELLA TRACKING ISSUES. --> IT HAD AN UNIDENTIFIABLE IMPLANT IN PLACE AND REMAINED.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17038469 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PLACED POST SPACER AND HAS CONTINUED DRAINING. SURGEON CHOSES I&D WITH COMPONENT EXCHANGE OF ANY MODULAR OR REMOVABLE COMPONENT AND PLACEMENT OF ANTIBIOTIC BEADS. PROCEDURE PERFORMED UNEVENTFULLY AND NO PATIENT HARM OCCURRED. IT WAS ALSO REPORTED THAT THE FEMORAL COMPONENT WAS LOOSE AT THE BONE TO IMPLANT INTERFACE. FEMORAL COMPONENT WAS YET TO INGROW DUE TO SHORT DURATION IN SITU. SURGICAL DELAY WAS UNKNOWN. DOI:(B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 16860170 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PLACED POST SPACER AND HAS CONTINUED DRAINING. SURGEON CHOSE I&D WITH COMPONENT EXCHANGE OF ANY MODULAR OR REMOVABLE COMPONENT AND PLACEMENT OF ANTIBIOTIC BEADS. PROCEDURE PERFORMED UNEVENTFULLY AND NO PATIENT HARM OCCURRED. IT WAS ALSO REPORTED THAT THE FEMORAL COMPONENT WAS LOOSE AT THE BONE TO IMPLANT INTERFACE. FEMORAL COMPONENT WAS YET TO INGROW DUE TO SHORT DURATION IN SITU. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 16860169 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO STILL DRAINING AND SURGEON ELECTED TO WASH OUT AND CHANGE COMPONENTS THAT HE WAS ABLE TO. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 16417785 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A DVT IN HER ARM FROM A PIC LINE POST OPERATIVELY. SHE WAS ANTICOAGULATED AND CAUSED A SWELLING IN HER KNEE. INCISION UNFORTUNATELY CAME OPEN DUE TO INCREASED SWELLING AND AN I&D WAS PERFORMED. SURGEON CHOSE TO EXCHANGE MODULAR COMPONENTS AT THE TIME OF SURGERY. NO PATIENT HARM OCCURRED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Wound Dehiscence

  MAUDE report 15804081 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT APPEARED TO BE INFECTED AND THE SURGEON CHOSE TO PERFORM A SINGLE STAGE REVISION WITH DUAL SET UP AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. IMPLANTS WERE NOT LOOSE, HOWEVER NEITHER SLEEVE WAS INGROWN FURTHER CONFIRMING PRESENCE OF INFECTION. CEMENT USED WAS LIKELY DEPUY 2 WITH GENT BUT IT WAS HOSPITAL OWNED SO NO RECORD OF QUANTITY OR LOT INFO. (SOME COMPONENTS WERE IMPLANTED ON (B)(6) 2021 WHEN A FEMORAL SIDE REVISION WAS PERFORMED. A DER WAS SUBMITTED BUT I DO NOT HAVE A NUMBER.) THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13666658 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STILL PRESENTING SIGNS OF INFECTION. SURGEON DECIDED TO PERFORM A WASH OUT AND REMOVE IMPLANTS AND REPLACED WITH NEW IMPLANTS. THERE WERE NO INSTRUMENTS BROKEN AND NO SURGICAL TIME ADDED TO CASE. THERE WAS NO NEW INFORMATION THAT THE SALES REP CAN PROVIDE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13357988 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO DRAIN. ALL COMPONENTS WERE REMOVED AND REPLACED IN A SINGLE STAGE REVISION UTILIZING A DUAL SET UP. THE CEMENT WAS A DEPUY PRODUCT BUT THE INFORMATION WAS NOT AVAILABLE AS IT WAS A HOSPITAL OWNED INVENTORY AND NOT ON THE PAPERWORK. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 13168162 ↗
• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH A DRAINING WOUND. SURGEON SUSPECTS INFECTION AND FINDS PUSS IN THE KNEE. SURGEON PERFORMS A ONE STAGE KNEE REVISION WITH A DUAL SET UP AND PLACEMENT OF ANTIBIOTIC BEADS. TWO SURGERY DATES RELATE TO THIS DER AS A POLY EXCHANGE WAS PERFORMED ON (B)(6) 2021 WHERE A DER WAS SUBMITTED. CEMENT UTILIZED WAS A DEPUY PRODUCT, HOWEVER PART AND LOT INFO ARE UNAVAILABLE AS IT IS HOSPITAL OWNED AND NOT ON A PAPERWORK. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 12922938 ↗
• InjuryAug 2, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF LPS FUSION SPACER AND KNEE CONTAMINATION. IT WAS REPORTED THAT THE IMPLANT CAME THROUGH HIS SKIN AND BECAME CONTAMINATED. ALL COMPONENTS WERE REMOVED, A THOROUGH I AND D PERFORMED, AND A NEW COMPONENTS WERE PLACED ALONG WITH ANTIBIOTIC BEADS. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 12263650 ↗