ATTUNE 1511-01-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295436492), received between Jul 18, 2019 and Nov 20, 2025 — classified as 22 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN INITIAL SURGERY ON KNEE JOINT WITH ANOTHER COMPANY¿S PRODUCTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO AN INFECTION WITH CEMENT MOLD. ON (B)(6) 2025 THE PATIENT UNDERWENT A DEBRIDEMENT DUE TO REINFECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT COMPLETE REMOVAL AND MOLD REPLACEMENT WITH GENTAMICIN CEMENT FROM ANOTHER COMPANY AND FOUR TO SIX (4-6) WEEKS OF ANTIBIOTIC ADMINISTRATION IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 23607474 ↗
• InjuryJul 21, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE WAS REVISION OF AN ATTUNE REVISION CONSTRUCT. REASON FOR REVISION DUE TO LOOSENING OF TIBIAL STEM, FEMORAL SLEEVE AND STEM RESULTING IN SUBSIDENCE. NO SIGN OF INFECTION. RIGHT SIDE WAS IMPACTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22553900 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY CONSTRUCT (ZIMMER). THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 18713450 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. WAS THERE A SURGERY DELAY? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO.

  Patient problems: Unspecified Infection

  MAUDE report 18697439 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR EXCISION SCAR NEUROMA RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: NONE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17192007 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. 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 (UNSPECIFIED).

  Patient problems: Pain

  MAUDE report 16762795 ↗
• InjuryFeb 14, 2023Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY VIA TKA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THERE WAS THE POSSIBILITY OF METALLOSIS DUE TO MICRO-MOTION OF THE TAPER LOCK BETWEEN FEMORAL SLEEVE AND FEMORAL COMPONENT. THERE WAS ALSO THE POSSIBILITY OF LOOSENESS DUE TO METALLOSIS. THE REVISION SURGERY WAS DONE ON AN UNKNOWN DATE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT IT MIGHT BE A LOOSE TAPER LOCK. HE WANT THE INVESTIGATION TO IDENTIFY THE SOURCE OF THE METAL DEBRIS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 16371320 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2021. (LEFT KNEE) TREATMENT: INJECTED MEDICATION; DIAGNOSTIC INTERVENTION.

  Patient problems: Synovitis

  MAUDE report 15198435 ↗
• 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 14841120 ↗
• InjuryMar 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY CHANGE FROM REVISION KNEE 3 YEARS AGO. NO ISSUE WITH POLY, LIMITED FLEXSION APPROXIMATELY 85°. PRESENT IN BOTH KNEES (ONE DPS / ONE EXATECH). DOI: (B)(6) 2019.

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 13916468 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATCH OF SYNOVITIS LATERAL ASPECT OF LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2018, DATE OF EVENT: (B)(6) 2021, (LEFT KNEE). TREATMENT: UNSPECIFIED INJECTED MEDICATION AND DIAGNOSTIC INTERVENTION.

  Patient problems: Synovitis

  MAUDE report 12786605 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DAIR PROCEDURE FOR INFECTION. PRIMARY SURGERY EARLY 2021, DR.(B)(6) HOSPITAL. PROCEDURE TODAY DAIR PROCEDURE FOR INFECTION DR SETH TARRANT WHO DOES NOT APPEAR ON CST LIST. DOI: 2021. DOR: (B)(6) 2021. UNKNOWN SIDE.

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

  MAUDE report 12533933 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE DELAY IN THE CASE WAS TO CABLE THE FEMUR AFTER IMPLANTING ATTUNE REV FEMUR WITH A 30 SLEEVE AND 14X60 STEM. A SURGICAL DELAY OF 20 MINUTES." DOI: (B)(6) 2021.

  Patient problems: Limb Fracture

  MAUDE report 12481188 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO REVISION PROCEDURE FOR THIS PATIENT ON (B)(6) 2020. THE PROCEDURE THAT TOOK PLACE FOR THIS PATIENT ON (B)(6) 2020 WAS THE PRIMARY PROCEDURE - NOT A REVISION.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 12269325 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: ARTHROSCOPY OF RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11633542 ↗
• InjuryMar 19, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM A COMPETITOR TKA TO AN ATTUNE REVISION KNEE. ALL OF THE PROPER PREP AND 1MM OVER REAM OF THE STEMS WAS DONE. THE TRIAL SAT PERFECTLY AND THE REAL IMPLANT WAS CONSTRUCTED TO LOOK EXACTLY LIKE THE TRIALS. THE REAL FEMORAL CONSTRUCT WOULD NOT SEAT FULLY. IT SAT 12MM PROUD AND RESULTED IN THE KNEE BEING MISBALANCED IN FLEXION AND EXTENSION. THERE WAS A 3 MINUTE SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 11529250 ↗
• InjuryOct 27, 2020Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THIS PATIENT WAS HAVING AN ATTUNE REVISION KNEE. THE PATIENT HAD A COMPETITOR PRODUCT IN THE KNEE. THE ATTUNE KNEE WAS PREPARED AS PER TECHNIQUE. THE FEMORAL AND TIBIAL STEM WERE OVERREAMED BY 1MM. THE BROACHES FOR THE FEMUR AND TIBIA SAT PERFECTLY, AND THE TRIALS SAT CORRECTLY. THE IMPLANTS WERE ASSEMBLED CORRECTLY. THE TIBIAL TRAY SAT PROUD 2MM. LUCKILY, WE COULD DOWNSIZE THE INSERT. DURING IMPACTION OF THE FEMORAL CONSTRUCT, THE PATIENT'S FEMUR CRACKED ON THE ANTERIOR SURFACE. THE SURGEON HAD TO USE A CABLE TO KEEP THE CRACK FROM PROPAGATING. THE SURGEON USED PARTIAL COATED SLEEVES ON BOTH THE FEMUR AND TIBIA. THESE ITEMS SITTING PROUD, OR CRACKING BONE IS A COMMON ISSUE WITH THIS SYSTEM. THE PRESSFIT IS TOO MUCH. THIS WAS NOT AN ISSUE WITH THIS SURGEON AND THE CLOSE TO A THOUSAND SIGMA REVISION KNEES THAT HE PERFORMED. THERE WAS A SURGICAL DELAY OF 15 MINUTES. RIGHT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10742557 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INSTABILITY OF LATERAL LIGAMENTS. ON (B)(6) 2020, THESE REVISION IMPLANTS WERE REMOVED AND REPLACED WITH IMPLANTS FROM ANOTHER COMPANY. SIDE: LEFT.

  Patient problems: No Code Available

  MAUDE report 10242081 ↗
• MalfunctionJun 26, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS PREPPED FOR STEMS AND SLEEVES ON BOTH THE FEMUR AND TIBIA. THE SURGEON OVER-REAMED FOR THE STEMS BY 1 MM AND PREPPED FOR SLEEVES. THE TRIAL CONSTRUCT SAT PERFECTLY. THE REAL FEMORAL CONSTRUCT WOULD NOT SEAT FULLY. IT SAT PROUD ABOUT 4 MM. THE SURGEON REMOVED THE FEMORAL COMPONENT AND CLEANED THE CEMENT OFF ITS BACKSIDE AND OFF THE PATIENT. THE SURGEON CHECKED HIS FEMORAL CUTS AND SEATED THE BROACH AGAIN. THEN HE TRIED THE REAL CONSTRUCT AGAIN AND IT SAT PROPERLY. NEW CEMENT WAS MIXED AND THE REAL CONSTRUCT WAS IMPLANTED. IT IS UNKNOWN WHY THE CONSTRUCT DID NOT SIT PROPERLY THE FIRST TIME. THOUGHT THAT THE PRESSFIT FOR THIS CONSTRUCT IS TOO MUCH. CLEANING, PREPPING AND RE-CEMENTING COST THE SURGEON A LOT OF TIME IN THE OR. DOE: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10202442 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE SURGEON REMOVED ALL PARTS AND IMPLANTED TEMPORARY COMPONENTS. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10198228 ↗
• MalfunctionJun 19, 2020Inadequacy of Device Shape and/or Size; Difficult to Advance; Inadequacy of Device Shape and/or Size; Difficult to Advance

  IT WAS REPORTED THAT THE SURGEON OVER REAMED 1MM FOR THE FEMORAL STEM, AND BROACHED AND TRIALED APPROPRIATELY. THE REAL FEMORAL CONSTRUCT SAT PROUD AND WOULD NOT FULLY SEAT. IT SAT PROUD 3MM. DUE TO THIS, THE PATIENT HAS A GAP MISBALANCE, AND WILL NOT FULLY EXTEND. THE PRESSFIT FOR THIS CONSTRUCT IS TOO MUCH. UNLESS THE SURGEON PLANS TO BREAK FEMURS TO SEAT FULLY, IT IS VERY DIFFICULT IF NOT IMPOSSIBLE TO SEAT FULLY LIKE THE TRIAL CONSTRUCT SAT. A SURGICAL DELAY OF 20 SECONDS WAS NOTED. DOE: (B)(6) 2020.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable

  MAUDE report 10176541 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ATTUNE REVISION, PATIENT REQUIRED ALL IMPLANTS REMOVED DUE TO INSTABILITY AND INFECTION (NO COLLATERAL LIGAMENTS) FROM REVISION (B)(4) (B)(6) 2020 FROM A POLY EXCHANGE DUE TO INSTABILITY.

  Patient problems: Joint Dislocation; Joint Disorder; No Code Available; Unspecified Infection

  MAUDE report 9942973 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION KNEE DUE TO INFECTION. PRIMARY SURGEON PROF. (B)(6). FEMALE PATIENT ID: (B)(6). IMPLANTS STILL IMPLANTED: 1 X 151820038 ATTUNE MEDIAL DOME PAT 38MM - LOT 9268987. 1 X 151314060 ATUNE PRESSFIT STR STEM14X60MM - LOT J1946P. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9847665 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8803092 ↗