ATTUNE 1520-20-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295542599), received between Jun 12, 2023 and Apr 27, 2026 — classified as 15 injuries.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSTABILITY. PATIENT WAS UNSTABLE. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25000892 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA WITH AUGMENTS, POLY AND FEMUR WERE ALL REMOVED DUE TO INSTABILITY. ALL PIECES WERE REMOVED FROM THE PT. AND THE FIELD IMMEDIATELY IN THEIR ENTIRETY AND THERE WAS NO HARM DONE TO THE PATIENT. I HAVE NO FURTHER INFORMATION. AFFECTED SIDE- RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 24896426 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION AND DISEASE, RESULTING IN THE REPLACEMENT OF THE POLY INSERT. NO FURTHER INFORMATION IS AVAILABLE. DOI-(B)(6) 2026. DOR-(B)(6) 2026. AFFECTED SIDE-UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24756674 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD KNEE INSTABILITY. INSERT WAS EXCHANGED FOR A THICKER SIZE. NO DELAYS, NO PATIENT INJURY. NO FURTHER INFORMATION WAS KNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23745045 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH POLY SWAPPED DUE TO PATIENT FALLING. NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING, DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Fall

  MAUDE report 23648408 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT WAS PERFORMED DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21761962 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR : OTHER SURGICAL SITE / DELAYED WOUND HEALING ON (B)(6) 2024, MEDICAL RECORDS NOTE THAT THE PATIENT IS NOW 6 WEEKS OUT FROM RIGHT KNEE. CLINICAL IMPRESSION IS THAT THE PATIENT IS DOING WELL. IT WAS NOTED THAT THE PATIENT HAS A LOT OF ADIPOSE TISSUE BELOW THEIR KNEE. (B)(6) 2024 MEDICAL RECORDS NOT THE PATIENT¿S CHIEF COMPLAINT IS WOUND CARE, FOLLOW-UP STATUS POST KNEE ARTHROPLASTY. THE PATIENT IS ON ANTIBIOTICS, THE PATIENT HAS THREE AT LEAST THREE POCKETS IN THE WOUND AND ONE IS DRAINING PUS. THE PATIENT HAD A DEBRIDEMENT WITH SCALPEL IN THE OFFICE. (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE WOUND. PHYSICAL EXAMINATION NOTES THERE ARE TWO NECROTIC AREAS AT THE DISTAL PORTION OF THEIR INCISION. THE PLAN IS FOR THE PATIENT TO HAVE DEBRIDEMENT AND WOUND VAC PLACEMENT. (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE SUPERFICIAL AND DRAINAGE. STATUS POST SUPERFICIAL I AND D OF THE RIGHT KNEE ALONG WITH WOUND VAC PLACEMENT, DOING WELL.

  Patient problems: Fluid Discharge; Impaired Healing; Necrosis; Purulent Discharge

  MAUDE report 20733006 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR THE RIGHT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE. DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 19/SEP/24. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: :NO INFORMATION PROVIDED.

  Patient problems: Cardiogenic Shock; Cardiovascular Dysfunction/Insufficiency; Low Blood Pressure/ Hypotension; Pulmonary Embolism

  MAUDE report 20438882 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTION 5 MONTHS POST OP. INCISION AND DRAINAGE WITH POLY SWAP. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20238552 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC INFECTION, INFECTION - DEEP. DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 17/JUL/2024. DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED.

  Patient problems: Cyst(s); Erythema; Fall; Loss of Range of Motion; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 19863269 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER EXCHANGE AND WASHOUT TO RULE OUT INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19709270 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D WASH OUT, POLY SWAP. DOI: (B)(6) 2023 DOR: (B,)(6) 2024 AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 18757198 ↗
• InjuryJan 9, 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 EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: 01 FEB 2023. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18473914 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FINISHING THE TKA ON (B)(6) 2023, THE PATIENT FELT A POP IN HER KNEE. THE DOCTOR BROUGHT HER BACK IN AND DID AN MCL REPAIR. AFTER THE REPAIR WAS COMPLETE, HE UPSIZED THE POLY INSERT FROM AN 8MM TO A 10MM. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 17873418 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED DUE TO INFECTION. DURING THE PROCEDURE, THE PATIENT'S KNEE WAS IRRIGATED AND DEBRIDED, AND HIS TIBIAL INSERT WAS REPLACE WITH A NEW INSERT OF THE SAME SIZE AND THICKNESS. SURGICAL DELAY UNKNOWN. THIS PATIENT'S KNEE WAS ALSO REVISED TEN DAYS EARLIER, ON (B)(6) 2023, THE RESULT OF A PRIOR KNEE INFECTION. DURING THAT PROCEDURE, THE PATIENT'S ANTIBIOTIC CEMENT SPACERS WERE REMOVED AND REPLACED BY NEW ATTUNE KNEE COMPONENTS (IMPLANTS). THIS PATIENT'S PRIMARY KNEE COMPONENTS WERE IMPLANTED ON (B)(6) 2022. THE PATIENT'S KNEE BECAME INFECTED. ON (B)(6) 2022, HIS PRIMARY TIBIAL INSERT WAS REMOVED, HIS KNEE WAS ALSO THOROUGHLY IRRIGATED AND DEBRITED, AND A REPLACEMENT INSERT WAS IMPLANTED. THE INFECTION DID NOT CLEAR UP, SO ALL OF THE PATIENT'S KNEE COMPONENTS WERE REMOVED ON (B)(6) 2023 AND REPLACED BY AN ANTIBIOTIC SPACERS. THE IMPLANTATION OF THE SPACERS WAS THE FIRST STAGE OF THE PLANNED TWO STAGE REVISION PROCEDURE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17105785 ↗