ATTUNE 1516-20-908Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295046158), received between Dec 13, 2018 and Dec 5, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR POLY SWAP. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23731104 ↗
• InjuryNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SIGNS OF INFECTION IN THE PAST 48 HRS. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20723171 ↗
• MalfunctionOct 27, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  WHAT I CAN REMEMBER IT WAS JUST THE PRODUCT IN THE PICTURE WHICK WAS AFFECTED. I HAVE NO FURTHER INFORMATION. CAN IT BE VERIFIED HOW MANY DEVICES ARE AFFECTED BY THIS ISSUE? "ATTACHED PICTURES OF A TIBIA PLATE THAT TURNED OUT TO BE PUNCTURED ALL THE WAY INTO THE IMPLANT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021994 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. I AND D OF KNEE AND POLY SWAP WAS PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9546100 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF KNEE JOINT IMPLANTS AND INSERTION OF CEMENT SPACER; ATTUNE IMPLANTS WERE REMOVED DUE TO INFECTION AND NOT BECAUSE THEY HAD FAILED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8161312 ↗