ATTUNE 1513-14-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295043645), received between Sep 17, 2022 and Sep 10, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION WHICH CAUSED FEMUR TO LOOSEN. THERE WAS FEMORAL LOOSENING AT THE BONE AND CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20182143 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTS REMOVED AND REPLACED DUE TO SUSPECTED INFECTION. IMPLANTS WERE PLACED ON 2 DATES PER THE RECORDS, (B)(6) 2019(FIRST 5 ITEMS LISTED) AND (B)(6) 2022. PATIENT EXPERIENCED REPEATED EFFUSIONS. SURGEON HAS SENT MULTIPLE ASPIRATIONS BUT NO CULTURES WERE NOT POSITIVE. CELL COUNTS AND LAB VALUES WERE ELEVATED, BUT NOT REACHING A LEVEL TO DIAGNOSE INFECTION. DURING THE PROCEDURE, 2 SEPARATE TISSUE SAMPLES WERE SENT TO PATHOLOGY, AND 3 AND 4 WBC/HPF WERE FOUND, AGAIN ELEVATED BUT NOT DEFINITIVE. SURGEON CHOSE TO REMOVAL ALL COMPONENTS AND REPLACE IN A ONE STAGE FASHION AFTER A THOROUGH DEBRIDEMENT AND IRRIGATION. ANTIBIOTIC BEADS WERE PLACED IN CANALS AND SURROUNDING SOFT TISSUES AND VANCOMYCIN WAS ADDED TO GENT CEMENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 15443148 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTS REMOVED AND REPLACED DUE TO SUSPECTED INFECTION. IMPLANTS WERE PLACED ON 2 DATES PER THE RECORDS, (B)(6) 2019(FIRST 5 ITEMS LISTED) AND (B)(6) 2022. PATIENT EXPERIENCED REPEATED EFFUSIONS. SURGEON HAS SENT MULTIPLE ASPIRATIONS BUT NO CULTURES WERE NOT POSITIVE. CELL COUNTS AND LAB VALUES WERE ELEVATED, BUT NOT REACHING A LEVEL TO DIAGNOSE INFECTION. DURING THE PROCEDURE, 2 SEPARATE TISSUE SAMPLES WERE SENT TO PATHOLOGY, AND 3 AND 4 WBC/HPF WERE FOUND, AGAIN ELEVATED BUT NOT DEFINITIVE. SURGEON CHOSE TO REMOVAL ALL COMPONENTS AND REPLACE IN A ONE STAGE FASHION AFTER A THOROUGH DEBRIDEMENT AND IRRIGATION. ANTIBIOTIC BEADS WERE PLACED IN CANALS AND SURROUNDING SOFT TISSUES AND VANCOMYCIN WAS ADDED TO GENT CEMENT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 15443147 ↗