ATTUNE 1516-30-907Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295048244), received between Jan 11, 2021 and Mar 7, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 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.

• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED BILATERAL TKA. FOLLOWING SURGERY, PATIENT WAS SATISFIED WITH RIGHT SIDE. HOWEVER LEFT SIDE HAS GIVEN CONSISTENT PAIN ISSUE EVER SINCE OPERATION. NO VISIBLE LOOSENING ON X-RAY AND NO EVIDENCE OF INFECTION. DECISION WAS MADE TO REVISE LEFT TKA TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 18856153 ↗
• InjuryMar 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED (FEMUR TRANSLATED ANTERIORLY). REVISED FEMUR TO CRS.

  Patient problems: Joint Dislocation

  MAUDE report 11404453 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STILL LEFT TOTAL KNEE ARTHROPLASTY/ADHESIONS; FAILURE TO PROGRESS IN PHYSICAL THERAPY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020.

  Patient problems: Adhesion(s)

  MAUDE report 11148214 ↗