ATTUNE 1513-10-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295043522), received between Nov 9, 2021 and Aug 18, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was admitted through the emergency department for suspected infection of a static spacer used for treatment of infection. Aspiration showed gross purulence. The tibial side components, including segments and adapters, were removed, and lack of ingrowth was noted, further supporting infection. The femoral side components were reported to be well fixed and were left in place. The patient had a long history of unresolved infection. No allegation was made against any components, and no patient harm or surgical delay was reported. Cement used in the spacer was identified as DePuy 2 with gentamicin; however, it was hospital-owned, and no quantity, lot, or additional identifying information was available. The cement was reportedly stored in the hospital supply room and hand mixed in an open bowl with high-dose antibiotics.Affected side: Right knee.

  Patient problems: Unspecified Infection

  MAUDE report 50304721 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2021; (RIGHT KNEE). TREATMENT: KNEE REVISION ON (B)(6) 2021. THE REVISION DATE FOR THE LOOSENING AND INFECTION IS (B)(6) 2021. (THIS WAS DOCUMENTED IN THE EVENT DESCRIPTION AS (B)(6) 2021 BUT THIS WAS A CLERICAL ERROR). THE REVISION DATE FOR THIS PC IS (B)(6) 2021. ALL IMPLANTS WERE REVISED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14013115 ↗
• InjuryNov 9, 2021Migration; Migration

  1. PLEASE CONFIRM PRESENCE OF INFECTION? BACTERIA HAVE BEEN GROWN FROM THE SAMPLES TAKEN AT THE TIME OF REMOVING THE ATTUNE REVISION , INDICATING AN INFECTION. 2. WAS LOOSENING DUE TO INFECTION? YES. 3. IT WAS INDICATED IN THE EVENT DESCRIPTION THAT '' THE TIBIA APPEARS TO HAVE MOVED/ SUBSIDED ON THE MEDIAL SIDE WITH THE LONG 160MM CANAL FILLING STEM (LONG STEM WAS REQUIRED TO BYPASS THE ORIGINAL STEM) ABUTTING THE LATERAL CORTEX WHICH SHOWS SIGNS OF REMODELING. '' PLEASE CLARIFY, DID THE TIBIA SUBSIDE? YES IT DID. MOVING INTO VARUS WITH THE DISTAL TIP ABBUTTING THE DISTAL LATERAL CORTEX. 4. CAN YOU PLEASE ADVISE WHO THE MANUFACTURER OF THE PATELLA WAS. I WOULD GUESS IT WAS A ZIMMER BIOMET PATELLA.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12780593 ↗