ATTUNE 1517-10-418Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295055853), received between Jun 7, 2019 and Oct 22, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND FELT UNSTABLE. I&D W POLY EXCHANGE AND PATELLECTOMY PERFORMED. PATELLA ORIGINALLY IMPLANTED ON (B)(6) 2023. THERE WAS NO LOOSENING AND NO ADVERSE CONSEQUENCES OCCURRED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 20504215 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND TORE THE INCISION OPEN. SURGEON PERFORMED I & D WITH POLY SWAP. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 19939103 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18424983 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND MILD REDNESS. THE PATIENT HAD A KNEE REVISION DONE ON (B)(6) 2020, THE PREVIOUS KNEE IMPLANT WAS NOT DEPUY. THE SURGEON FELT THAT THE PATIENT WOULD BENEFIT FROM AN I&D AND POLY EXCHANGE. THE SIZE 4 18MM INSERT WAS REMOVED AND THE KNEE WAS THOROUGHLY WASHED OUT. A TRIAL REDUCTION WAS PERFORMED WITH A SIZE 20MM INSERT AND IT WAS FOUND TO BE STABLE. THE REAL IMPLANT WAS OPENED & INSERTED AND THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Erythema; Pain

  MAUDE report 11957177 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED ALL COMPONENTS AND PUT IN A TEMPORARY ANTIBIOTIC KNEE SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11517454 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. PATIENT HAD A ATTUNE REVISION SURGERY ON (B)(6) 2019. ON (B)(6) 2019, PATIENT PRESENTED IN THE DOCTORS OFFICE WITH AN INFECTED KNEE. THE PATIENT WAS BROUGHT TO THE OR FOR AN I&D AND INSERT EXCHANGE. THE ORIGINAL ATTUNE CRS INSERT SIZE 4 X 18MM INSERT WAS REMOVED AND A NEW INSERT OF THE SAME SIZE WAS REIMPLANTED. ALL OTHER IMPLANTS WERE WELL FIXED AND RETAINED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8678666 ↗