ATTUNE 1506-70-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295492115), received between Jan 10, 2020 and Jul 9, 2026 — classified as 9 injuries.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Feb 22, 2021Class IITerminated

   Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

   Z-1314-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF AN ATTUNE CRFB CONSTRUCT DUE TO INFECTION. ALL IMPLANTS WERE EXPLANTED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 25767205 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE WAS REVISED DUE TO STIFFNESS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 19491495 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LARGE EFFUSION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2024. (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 18555372 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT KNEE REVISION AND PLACEMENT OF SPACER DUE TO INFECTION. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17748208 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STIFFNESS AND PAIN IN LEG NOT FEELING TO GO INTO FULL EXTENSION. SURGEON SCHEDULED POLY EXCHANGE WITH POSSIBLE TIBIA REVISION. DURING SURGERY, THE SURGEON WANTED TO REVISE TIBIA WITH A ROTATING POLY CR. SURGERY WAS SUCCESSFUL. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 16225698 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT KNEE INFECTION. IMPLANTS REMOVED AND TEMPORARY ABX SPACER WAS IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 15868806 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TKR; ASPIRATION DONE TO CONFIRM INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10397513 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS. FEMUR, INSERT AND TIBIAL WERE ALL REMOVED. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10165132 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9577626 ↗