ATTUNE 1506-40-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295042822), received between Sep 27, 2019 and Aug 12, 2024 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K160700, K241000); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE IN REGARDS TO (B)(4). THIS CASE LOGGED TO CAPTURE THE FIRST STAGE REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19960719 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(4) CLINICAL ADVERSE EVENTS RECEIVED FOR CREPITUS/CLUNKING WITH ASSOCIATED MEDIAL RIGHT KNEE PAIN DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: POSSIBLY PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 14/OCT/2022 DATE OF IMPLANT: INFORMATION NOT PROVIDED DATE OF REVISION: INFORMATION NOT PROVIDED DEVICE LOCATION: RIGHT TREATMENT/IMPACT: PARTIAL KNEE REVISION USING ATTUNE PS FB GEOGRAPHICAL LOCATION: CANADA.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 19760065 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18934522 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16088460 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MANIPULATION UNDER ANAESTHETIC (MUA) TO ADDRESS STIFFNESS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2019 (REVISION SURGERY, ALL PRODUCTS). DOE: (B)(6) 2019. (LEFT KNEE).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 14111143 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13618182 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED KNEE. SURGEON CONDUCTED A STAGED REVISION AND PULLED ALL IMPLANTS. DOI: (B)(6) 2019. DOE: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13308998 ↗
• InjuryJan 6, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AD 07 DEC 2021. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, INSTABILITY, AND ASEPTIC LOOSENING. UPON ENTERING THE JOINT, SCARRING WAS NOTED TO BE RESECTED. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE, INTERFACE NOT PROVIDED. THE TIBIAL COMPONENT WAS ALSO NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS REVISED AND REPLACED WITH COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2019; DOR: (B)(6) 2021: (RIGHT KNEE).

  Patient problems: Joint Laxity; Pain; Scar Tissue

  MAUDE report 13175468 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE EXTRACTED AND A TEMPORARY ABX SPACER WAS PLACED. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12324884 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. DOI: (B)(6) 2017; DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12308069 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MULTIPLE INFECTIONS AT THE UNKNOWN CAUSES. DOI: (B)(6) 2019; (B)(6) 2020 (POLY EXCHANGE DUE TO INSTABILITY CAPTURED IN (B)(4)), DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11171609 ↗
• MalfunctionNov 5, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TKA. THE SURGEON COULD NOT GET THE POLY TO LOCK INTO THE TRAY. A SECOND POLY WAS OPENED & IMPLANTED. A 15 MINUTE SURGICAL DELAY WAS REPORTED. DOE: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10792696 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED LOOSE ATTUNE TRAY (B)(6) 2019 - REPLACED WITH STEMMED TIBIA AND CAPTURED IN (B)(4). IT WAS ALSO REPORTED THAT THE PATIENT IS MISERABLE WANTED ALL COMPONENTS REMOVED. THEY PLANNED A TC3 RP. FEMORAL COMPONENT IN TOO MUCH VALGUS. PATELLA, FEMUR, POLY AND TIBIA WERE REMOVED. TC3 CP - RESULT LESS VALGUS - BALANCED WELL, PATELLA TRACKED WELL. THERE WAS A SURGICAL DELAY OF 80 MINS. DOI: (B)(6) 2019 (TIBIAL TRAY, INSERT AND PRESSFIT STEM), (B)(6) 2018 (PATELLA AND FEMORAL), DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 9818136 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. CALLED FOR REMOVAL OF IMPLANTS AND PUTTING IN ANTIBIOTICS SPACER. NO ISSUES WITH IMPLANTS. NO OTHER INFO AVAILABLE. DOI: (B)(6) 2018; (B)(6) 2018 (INSERT); DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9129378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160700, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0631-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
• Z-0632-2022 · Jan 5, 2022 · Terminated
  ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
• Z-2348-2021 · Jul 1, 2021 · Terminated
  ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
• Z-1704-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
• Z-1703-2018 · Apr 16, 2018 · Terminated
  ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee