ATTUNE 1511-11-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295419648), received between Apr 17, 2019 and Oct 23, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 23369931 ↗
• 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 22236074 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK IN TO SEE DOCTOR WITH REDNESS (HOTNESS) AND PAIN IN PATIENT'S RTK. AFTER TESTING THEY DETERMINED THE KNEE TO BE SEPTIC AND A REVISION WAS NEEDED. UPON OPENING THE JOINT THE COMPONENTS APPEARED TO BE LOOSE AND THERE WAS BONE LOSS BETWEEN THE CEMENT MANTLE AND THE BONE. THE COMPONENTS WERE REMOVED, THE JOINT WAS THOROUGHLY IRRIGATED AND THE CANALS WERE REAMED OUT. AFTERWARDS NEW REVISION COMPONENTS WERE PLACED WITH ANTIBIOTIC CEMENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20267200 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DATE: BLANK. ALERT DATE: 28-JUN-2019. COUNTRY OF EVENT: OUS. PROCEDURE: TYPE OF REVISION - OPERATIVE DETAILS PART 1: FULL. PROCEDURE: KNEE REVISION USING ATTUNE - OPERATIVE DETAILS PART 2: PS RP OPERATIVE SIDE: LEFT DATE OF SURGERY: (B)(6) 2019 EVENT DESCRIPTION (DIAGNOSIS): OPERATIVE WOUND DEHISCED CENTRAL 8CMS: FURTHER REVISION SURGERY REQUIRED. UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR OPERATIVE WOUND DEHISCED CENTRAL 8CMS: WOUND DEHISCENCE REQUIRING DAIR. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: (B)(6) 2019. (LEFT KNEE). TREATMENT: IRRIGATION & DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19645688 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SLIGHT GAIT INSTABILITY LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: UNKNOWN IN 2023. (LEFT KNEE). TREATMENT: RECOMMENDATION FOR KNEE CONTROL IN THE ORTHOPEDIC DEPARTMENT DEPUY PRODUCTS USED (NO REVISION COMPLETED).

  Patient problems: Joint Laxity

  MAUDE report 17773541 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED KNEE DUE TO PATIENT DISCOMFORT, HE ALSO FELT THE KNEE WAS UNSTABLE. TIBIA SEEMED TO COME OUT EASIER THAN MOST, NOT SURE IF IT WAS LOOSE OR UNDERSIZED. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 15475606 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CONTRIBUTING FACTOR OF THE PATIENT'S LOSS IN QUAD CONTROL IS RELATED TO A NON-SPECIFIC NERVE ISSUE. THE ENTIRE FEMUR HAD BEEN DESECRATED, BUT THE JOINT LINE WAS RESTORED WITH A TOTAL FEMORAL IMPLANT.

  Patient problems: Joint Laxity; Nerve Damage; Unspecified Tissue Injury

  MAUDE report 12968515 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT TIBIA PERI-PROSTHETIC FRACTURE EVENT IS SERIOUS AND IS CONSIDERED SEVERE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELAYED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE).

  Patient problems: Bone Fracture(s); Cellulitis; Fall; Pain; Swelling/ Edema

  MAUDE report 12390898 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND STIFFNESS OF THE KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Muscular Rigidity; No Code Available; Pain

  MAUDE report 9811066 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: CLINICAL ADVERSE EVENT RECEIVED FOR JOINT STIFFNESS. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT; PROCEDURE RELATED: PROBABLY; DATE OF EVENT: 22-OCT-2019.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 9328351 ↗
• InjuryApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT WAS TREATED WITH A SURGICAL IRRIGATION & DEBRIDEMENT, WITH NO REVISION OF PRODUCTS.

  Patient problems: Hematoma; No Code Available

  MAUDE report 8524372 ↗