ATTUNE 1513-18-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10603295043720), received between Jul 18, 2019 and May 14, 2026 — classified as 54 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT DEVICES THAT WERE IMPLANTED IN (B)(6) 2025 ARE STILL IMPLANTED IN THE PATIENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 25177014 ↗
• 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 23592617 ↗
• 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 22105515 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST KNEE REPLACEMENT, AND HAD A PERIPROSTHETIC FRACTURE. IN A SEPARATE SURGERY, THEY ADDED A DISTAL FEMUR CONDYLAR PLATE. PATIENT FELL AGAIN, AND BROKE PROXIMAL TO THE PLATE. THE PLAN WAS TO REMOVE THE FEMUR, AND USE A DISTAL FEMUR REPLACEMENT. HOWEVER THE PATIENT HAS AN ACTIVE KNEE INFECTION, AND PUSS WAS IN THE SURGERY SITE. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall; Unspecified Infection

  MAUDE report 21962839 ↗
• InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20940875 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT AS PER SURGEON. THE PATIENT, HAD NICKEL ALLERGY. SURGEON REMOVED ALL COMPONENTS AND PUT IN COMPETITOR'S NICKEL FREE IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20831304 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). STUDY NO: DSJ-2016-02. 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 20507052 ↗
• 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 20239628 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT WAS FOUND TO BE REINFECTED, AFTER A 2-STAGE REVISION TKA. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. A SPACER WAS PLACED USING LPS COMPONENTS, INCLUDING THE PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND COATING THE PROSTHESIS WITH HIGH-DOSE ANTIBIOTIC CEMENT. NO DELAY OR PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION AGAINST ANY DEPUY COMPONENT. THEY WERE SIMPLY REMOVED, DUE TO INFECTION. CEMENT WAS HOSPITAL-OWNED, SO LOT INFORMATION WAS UNAVAILABLE, BUT THE SURGEON'S ROUTINE INVOLVED USING DEPUY 2 WITH GENT FOR REVISION CASES. ALL PART AND LOT INFORMATION WAS COPIED AND PASTED DIRECTLY FROM OPTIMIZE AND WAS ACCURATE, PER THAT SYSTEM. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19928231 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT: ON (B)(6) 2022, THE PATIENT WAS REVISED DUE TO PAIN, AND DEBONDING AT THE COMPETITOR TIBIAL TRAY AND DEPUY CEMENT INTERFACE. (B)(4) . AT REVISION, DEPUY COMPONENTS WERE IMPLANTED AT THAT TIME. DOI: (B)(6) 2021. DOR: (B)(6) 2022, (B)(4). AFFECTED SIDE: RIGHT KNEE. (B)(4). IT WAS REPORTED THAT THE PATIENT CONTINUES TO HAVE PAIN/SWELLING AND IS LOOKING AT ANOTHER REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19322961 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AFTER THE PATELLA TENDON RUPTURE. NO DELAY PATELLA IS AN IMPLANT AND NOT REMOVED. INSTABILITY NOT RELATED TO POLY WEAR DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18981178 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18934708 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING TO RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018 DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE) TREATMENT: DIAGNOSTIC INTERVENTION

  Patient problems: Swelling/ Edema

  MAUDE report 18928663 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: 1. UNKNOWN. LITTLE TO NO WAY TO CONFIRM OR RULE OUT INFECTION DURING A PROCEDURE. TISSUES LOOKED GOOD AT THE TIME OF SURGERY, HOWEVER, DUE TO PREVIOUS CONFIRMED INFECTION, IT WAS TREATED AS IF STILL INFECTED. 2. FEMORAL STEM WAS ALSO LOOSE.

  Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 18517754 ↗
• 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 FEBRUARY 2024. A SEPARATE COMPLAINT FOR THE FIRST REVISION WAS FILED UNDER (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18414076 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTED LTKA. SURGEON EXPLANTED THE ATTUNE REVISION IMPLANTS WE IMPLANTED ON (B)(6) 2023. THEY WASHED OUT THE KNEE IMPLANTED JUST A ATTUNE REV FEMORAL COMPONENT AND ATTUNE INSERT ALONG WITH SOME ANTIBIOTIC CEMENT SPACER AND ANTIBIOTIC BEADS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17368297 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTED LTKA. SURGEON EXPLANTED THE ATTUNE REVISION IMPLANTS WE IMPLANTED ON (B)(6) 2023. THEY WASHED OUT THE KNEE IMPLANTED JUST A ATTUNE REV FEMORAL COMPONENT AND ATTUNE INSERT ALONG WITH SOME ANTIBIOTIC CEMENT SPACER AND ANTIBIOTIC BEADS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17368292 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY IN FLEXION. DOCTOR DECIDED THAT WE WERE NOT GOING TO BE ABLE TO MAKE A CRS INSERT WORK WITH JUST BALANCING. HE DECIDED A HINGED KNEE WAS NECESSARY. WHILE REMOVING THE ATTUNE SLEEVE HE ENCOUNTERED MORE BONE LOSS THAN HE HOPED AND DECIDED THAT A DISTAL FEMORAL REPLACEMENT WAS NECESSARY. HE WOULD HAVE LIKED TO BE ABLE TO PUT A HINGED KNEE INTO THE ATTUNE REV SLEEVE. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16203365 ↗
• 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 15873519 ↗
• 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 15873088 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO THIGH PAIN. NO EVIDENCE OF INFECTION OR LOOSENING. SURGEON SUSPECTED THE PAIN MAY BE BEING GENERATED FROM A LARGE FEMORAL PRESS FIT STEM. AFTER DISCUSSIONS WITH THE PATIENT, THE DECISION WAS MADE TO DO A FEMORAL ONLY REVISION - PLAN A BEING TO REVISE THE FEMORAL SLEEVE TO A LARGER SIZE AND REDUCE THE FEMORAL STEM DIAMETER. PLAN B WOULD BE EITHER AN S-ROM HINGE OR LPS DISTAL FEMORAL REPLACEMENT DEPENDING ON BONE QUALITY FOLLOWING REMOVAL OF THE CURRENT ATTUNE REVISION FEMORAL COMPONENTS. THE REMOVAL PROCESS WAS NOT SIMPLE AS THE INITIAL COMPONENTS WERE WELL FIXED, AND AS A RESULT THERE WAS A COMPLETE FRACTURE OF THE LATERAL DISTAL FEMORAL CONDYLE AS WELL AS SIGNIFICANT METAPHYSEAL BONE LOSS OF THE DISTAL FEMUR WHILST ATTEMPTING TO REMOVE THE WELL FIXED SLEEVE AND STEM. PALACOS BONE CEMENT WAS USED IN ALL PROCEDURES. PLAN B WAS ACTIONED AND A LPS DISTAL FEMORAL REPLACEMENT WAS PERFORMED.

  Patient problems: Discomfort; Pain

  MAUDE report 14886464 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS FRACTURE OF THE FEMUR WHEN IMPLANTING A LEFT SIZE 7 REVISION ATTUNE KNEE FEMORAL COMPONENT WITH 30MM PARTIALLY COATED SLEEVE AND SIZE 18X60MM PRESSFIT STEM. THERE WAS A SURGICAL DELAY OF 50 MINUTES. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 14841129 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. INFECTION DEVELOPED FOLLOWING TKA. THE SURGEON STATED KNEE IS STILL INFECTED AND ELECTED TO REMOVE ALL IMPLANTS AND INSERT AN ANTIBIOTIC SPACER TO ADDRESS THE ISSUE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13536595 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR KNEE PAIN AND TMTJ OSTEOARTHRITIS RIGHT FOOT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2022, (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY, ORAL MEDICATION, AND INJECTED MEDICATION.

  Patient problems: Pain

  MAUDE report 13426811 ↗
• 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 13357989 ↗