ATTUNE 1506-70-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295492122), received between Dec 11, 2017 and Oct 15, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K170806, K233980); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH GROSS INFECTION WITH A DRAINING SINUS POST TKA. ALL COMPONENTS WERE REMOVED AND A THOROUGH I&D WAS PERFORMED AND A STATIC SPACER FASHIONED UTILIZING LPS COMPONENTS COATED WITH HIGH DOSE ANTIBIOTIC CEMENT. RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN THE FEMORAL AND TIBIAL CANALS ALONG WITH THE GUTTERS. THERE WAS NO DELAY NOR WAS ANY PATENT HARM NOTED. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23300194 ↗
• 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. WHICH 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 18022034 ↗
• 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 WHICH 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 18022033 ↗
• 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 18021916 ↗
• InjuryJun 24, 2020Migration; Migration

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL SUBSIDENCE. ORIGINAL IMPLANTATION DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10191185 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT OF LEFT TOTAL KNEE REVISION: THERE WAS INFECTION, REQUIRING FIRST STAGE REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9903394 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2017, DOR: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7103877 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170806, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1314-2021 · Feb 22, 2021 · Terminated
  ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee