ATTUNE 1506-70-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 10603295492078), received between Jun 26, 2018 and Sep 23, 2026 — classified as 108 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (27 reports).

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, 2021Terminated

   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 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that implants removed due to infection. No patient consequence. No surgical delay.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Unspecified Infection

  MAUDE report 50871733 ↗
• InjuryAug 13, 2026Loss of or Failure to Bond

  It was reported that patient was revised due to pain with knee. Upon revision for pain, infection was revealed. Grossly loose implants. And puss. Also tibial component was loose at cement to implant interface.DOI: (b)(6) 2022.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50239364 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED RIGHT TOTAL KNEE WITH ANTIBIOTIC SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25147966 ↗
• InjuryApr 30, 2026Migration

  ADDITIONAL INFORMATION RECEIVED: CAN YOU PLEASE PROVIDE THE IMPLANT AND EXPLANT DATE. UNKNOWN IMPLANT DATE. EXPLANT DATE WAS (B)(6) 2026 WHAT IS THE EXACT ALLEGATION OF THE REPORTED PRODUCT? MAL-ALIGNMENT. IS THIS SURGEON ERROR DURING THE PRIMARY IMPLANTATION PROCEDURE? YES.

  Patient problems: Pain

  MAUDE report 25047485 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANT FOR INFECTION. IMPLANTS DID NOT FAIL. THERE WAS NO LOOSENING. NO INSTABILITY. NO DELAY. NO OTHER INFO KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE:

  Patient problems: Unspecified Infection

  MAUDE report 24926255 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT REVISED TO NICKEL FREE IMPLANT. IMPLANT LOOSENING DUE TO SEVERE NICKEL ALLERGY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24800589 ↗
• InjuryMar 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL COMPONENT SZ5 CEMENTED FB TIBIAL BASE PLATE AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24518378 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ATTUNE PRIMARY WAS PUT IN A VALGUS KNEE. TRACKING WELL ON TABLE BUT SUBLUXES WHEN PATIENT FLEXES. LATERAL SIDE AND PATELLA FINE, MEDIAL SIDE - TIBIA MOVES ANTERIOR, FEMUR POSTERIOR. BEARING LOOKS SEATED ON XR, SIZES APPROPRIATE, NO LOOSE BODIES SEEN. IF WENT TO REVISION COULD I USE MEDIAL PIVOT BEARING IN THE PRIMARY TIBIA WITH PS FEMUR. ELDERLY LOW DEMAND PATIENT. NO REVISION SURGERY PLANNED.

  Patient problems: Joint Laxity

  MAUDE report 24443328 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND SURGEON SUSPICION OF INFECTION. DOI: UNKNOWN. DOR: (B)(60 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 24221365 ↗
• InjuryJan 6, 2026Migration

  IT WAS REPORTED THAT SURGEON NOTICED SOME TIBIAL FAILURES IN FIXED BEARING ATTUNE TIBIAS DONE APPROXIMATELY 5 YEARS AGO. THERE WAS A COLLAPSE OF TIBIAL TRAY. PATIENT MAY NEED A KNEE REVISION.

  Patient problems: Insufficient Information

  MAUDE report 23981525 ↗
• InjuryDec 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR LOOSENING OF THE FEMORAL COMPONENT, TIBIAL COMPONENT, AND PAIN. THE ARTICULAR SURFACE SHOWS MINOR YELLOWING AND SEVERE ABRASION AND PITTING.

  Patient problems: Pain

  MAUDE report 23923564 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO PAIN AND INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23478969 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 23463146 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISIONS DUE TO INSTABILITY AND PAIN. SURGEON DECIDED TO RESURFACE AN UN RESURFACED PATELLA. MAYBE DUE TO UNRESURFACED PATELLA, ALSO DECIDED TO INCREASE CONSTRAINT LEVEL TO HELP WITH STABILITY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23008829 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REPORTEDLY UNHAPPY WITH STABILITY. REVISION WAS PERFORMED. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22642127 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT INFECTED AND THE SURGEON REMOVED THE IMPLANTS TO DO A SPACER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22243568 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INFECTION. AT REMOVAL THE ACETABULAR LINER SHOWED MINOR YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 21986898 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO SURGERY FOR AN INFECTED KNEE. ALL KNEE IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. THERE WERE NO DELAYS OR BROKEN INSTRUMENTS. THE KNEE IS INFECTED BUT WAS NOT LOOSE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21420337 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS GROSSLY INFECTED. PATIENT FELL AND SPLIT OPEN KNEE. REMOVED ALL IMPLANTS. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection; Wound Dehiscence

  MAUDE report 20843812 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT WAS REVISED, DUE TO PAIN. DOI: UNK. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20777387 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR: OTHER SURGICAL SITE / DELAYED WOUND HEALING. ON (B)(6) 2024, MEDICAL RECORDS NOTE THAT THE PATIENT IS NOW 6 WEEKS OUT FROM RIGHT KNEE. CLINICAL IMPRESSION IS THAT THE PATIENT IS DOING WELL. IT WAS NOTED THAT THE PATIENT HAS A LOT OF ADIPOSE TISSUE BELOW THEIR KNEE. ON (B)(6) 2024 MEDICAL RECORDS NOT THE PATIENT¿S CHIEF COMPLAINT IS WOUND CARE, FOLLOW-UP STATUS POST KNEE ARTHROPLASTY. THE PATIENT IS ON ANTIBIOTICS, THE PATIENT HAS THREE AT LEAST THREE POCKETS IN THE WOUND AND ONE IS DRAINING PUS. THE PATIENT HAD A DEBRIDEMENT WITH SCALPEL IN THE OFFICE. ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE WOUND. PHYSICAL EXAMINATION NOTES THERE ARE TWO NECROTIC AREAS AT THE DISTAL PORTION OF THEIR INCISION. THE PLAN IS FOR THE PATIENT TO HAVE DEBRIDEMENT AND WOUND VAC PLACEMENT. ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT IS HAVING A FOLLOW-UP RIGHT KNEE SUPERFICIAL AND DRAINAGE. STATUS POST SUPERFICIAL I AND D OF THE RIGHT KNEE ALONG WITH WOUND VAC PLACEMENT, DOING WELL.

  Patient problems: Fluid Discharge; Impaired Healing; Necrosis; Purulent Discharge

  MAUDE report 20737879 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY VIA TKA. AFTER THE SURGERY, UNKNOWN DEFECT OCCURRED. WE ARE CONFIRMING ABOUT DETAILS. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL EVENT INFORMATION. THE PATIENT UNDERWENT A REMOVAL SURGERY DUE TO INFECTION ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20145530 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A KNEE REPLACEMENT AND IS EXPERIENCING PAIN ON THE SIDE OF HER KNEE WHEN GOING UP AND DOWN THE STAIRS. PATIENT REPORTS INSTABILITY WHEN WALKING AND HAS FALLEN A FEW TIMES. PATIENT FEELS WARMTH AND THE KNEE GETS HEAVIER AT NIGHT AND OFTEN TIMES HARD TO BEND. THE CT WITHOUT CONTRASTS DIDN'T SHOW ANYTHING IN THE SCAN. PATIENT EXCLAIMED SHE HAD SURGERY ON HER RIGHT KNEE 22 YEARS AGO WITH NO ISSUES. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 20085171 ↗
• MalfunctionAug 21, 2024Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT PACKAGING, THE SECOND WRAPPING WAS DEFORMED AND WHEN ATTEMPTING TO REMOVE THE LAST WRAPPING, IT WAS IMPOSSIBLE. UNABLE TO USE THE IMPLANT. ANOTHER IMPLANT WAS USED. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010846 ↗
• InjuryJul 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO LOOSENING (UNKNOWN COMPONENT(S) OR INTERFACE) AND PAIN. AT REVISION THE TIBIAL INSERT SHOWED MINOR YELLOWING.

  Patient problems: Pain

  MAUDE report 19830441 ↗