ATTUNE 1506-70-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 10603295492092), received between Dec 11, 2017 and Sep 23, 2026 — classified as 2 deaths, 66 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (16 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 74 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 ATTUNE PS FEM LT SZ 8 CEM, ATTUNE PS FB INSRT SZ 8 5MM, and ATTUNE FB TIB BASE SZ 7 CEM were involved in a left knee total knee arthroplasty revision case. The patient was reportedly unable to rehabilitate the knee after surgery and had very limited motion of 15 to 40 degrees. Revision surgery was performed to address the condition. During the procedure, all components were described as well fixed and well aligned, and no allegation was made against any of the components. A difficult exposure was performed with tissue elevation and removal of scarring. All well-fixed components were removed, and the revision total knee arthroplasty was completed without delay or patient harm. Range of motion was reported to be quite good, and a good outcome was expected. The cement was described as likely DePuy 2, hand mixed in an open bowl per surgeon protocol. The implanted devices were explanted.Affected Side: Left Knee.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 50868790 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. 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.

  Patient problems: Unspecified Infection

  MAUDE report 50177150 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement.A DePuy Synthes Implant was revised and reviewed for analysisReason for revision: Revision due to pain and stiffness. The non-articular surface of the fixed-bearing polyethylene tibial insert shows minor yellowing.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50163714 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced infection. All components removed. No additional information is availableDOI: (b)(6), 2026DOR: (b)(6), 2026Affected side: Left knee

  Patient problems: Unspecified Infection

  MAUDE report 50042275 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ACTIVE INFECTION IN THE KNEE JOINT. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED. THE BONE HAD BEEN EATEN AWAY BY BACTERIA UNDERNEATH THE IMPLANT. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24958771 ↗
• InjuryApr 8, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS HAVING PAIN AND SHOWED SIGNS OF HAVING A LOOSE IMPLANT. DOCTOR REVISED BOTH THE FEMORAL SIDE AND THE TIBIAL SIDE. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24821024 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24567378 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24367043 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24307962 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INSTABILITY OCCURRED AFTER A FALL. NOT AT THE FAULT OF DR / HOSPITAL/ OR IMPLANT. NO ISSUES WITH DEPUY KNEE PRODUCTS. DOI: (B)(6), 2022, DOR: (B)(6), 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 23795045 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT TOTAL KNEE DONE ON (B)(6) 2024. THE KNEE BECAME INFECTED AND THE PATIENT WAS BROUGHT IN FOR RESECTION. ALL COMPONENTS WERE REMOVED AND AN ARTICULATING KNEE SPACER WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23454685 ↗
• MalfunctionOct 30, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THERE WAS A PACKAGING ISSUE: ABSENCE OF A TEAR ALLOWING THE DOUBLE PACKAGING TO BE GRIPPED. THE DEVICE IN QUESTION WAS PLACED IN THE PATIENT. THE COMPLAINT IS MADE AFTER USE TO INDICATE THE ABSENCE OF A HANDLING LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426765 ↗
• InjuryOct 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23391367 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION FOR ANTERIOR KNEE PAIN. THE SURGEON REMOVED ANATOMIC PATELLA / SHAVED DOWN REMAINING BONE / REIMPLANTED DOME PATELLA. CHANGED TO MORE CONSTRAINT POLY AND COMPLETED LATERAL FACETECTOMY. THERE WAS NO DELAY IN SURGERY. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED OR SUCCESSFULLY COMPLETED.

  Patient problems: Pain

  MAUDE report 22903971 ↗
• 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 REVISED DUE TO PAIN AND INSTABILITY. AFTER ENTERING THE JOINT, THE PATELLA COMPONENT HAD FAILED AT THE BONE/CEMENT INTERFACE AND WAS FLOATING IN THE JOINT. COMPONENTS SHOWED SIGNS OF LOOSENING ON A BONE SCAN. COMPONENTS WERE REMOVED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22641951 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INCISION AND DRAINAGE WITH POLY EXCHANGE ON (B)(6) 2023 AS WELL AND HAD BEEN FIGHTING DRAINAGE. SURGEON ELECTED TO REMOVE AND PLACE A SPACER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22555404 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 22027437 ↗
• InjuryApr 4, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 INCLUDING PATELLA RESURFACING USING COMPETITOR CEMENT. THE PRIMARY OPERATION DID NOT HAVE ANY INTRAOPERATIVE ISSUES. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT KNEE REVISION FOR SYMPTOMS OF JOINT INSTABILITY, DIFFICULTY WALKING AND PAIN. INTRAOPERATIVELY THE SURGEON STATES BOTH FEMORAL AND TIBIAL COMPONENTS WERE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE SURGEON DID REQUIRE AN IMPACTOR AND MALLET TO REMOVE BOTH COMPONENTS. THE TIBIAL TRAY HAD ALSO SUBSIDED MEDIALLY. AS THE SURGEON WAS REMOVING THE PATELLAR COMPONENT, HE NOTED THERE WAS HETEROTOPIC BONE LATERALLY THAT WAS REMOVED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 21775520 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: ON (B)(6) 2024, THE PATIENT HAD A VISIT WITH THE PHYSICIAN ASSISTANT 5 MONTHS OUT FROM RECEIVING BILATERAL KNEE REPLACEMENTS. THE PATIENT¿S RIGHT KNEE IS NOW PAINFUL AND DOESN'T FEEL LIKE IT IS IMPROVING. A LOT OF SYNOVITIS, THICKENED SYNOVIUM AND FLUID IN THE KNEE WAS IDENTIFIED. ON (B)(6) 2024, THE PATIENT RETURNS TO THE SURGEON. ON XRAY THERE IS RESORPTION IN TIBIA ZONE 1 AND THE POSTERIOR FLANGE OF THE FEMUR. THE SURGEON SUSPECTS A CHRONIC LOW-GRADE INFECTION. HE PLANS TO EITHER PERFORM A 1-STAGE REVISION OR EXPLANT WITH A TEMPORARY ANTIBIOTIC SPACER DEPENDENT ON WHAT THE CULTURES GROW WITHIN THE NEXT COUPLE WEEKS.

  Patient problems: Extraskeletal ossification; Fluid Discharge; Pain; Synovitis; Unspecified Infection

  MAUDE report 20420930 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED AND PLACED ABX SPACER FOR INFECTION. NO BROKEN PARTS. ALL PIECES RETRIEVED. NO CASE DELAY. NO COMPLAINTS. NO OTHER INFORMATION KNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20290501 ↗
• MalfunctionSep 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  WHEN OPENING THE FIRST PACKAGE OF THE IMPLANTS, IT WAS NOTICED THAT THE SECOND PACKAGE WAS NOT IN OPTIMAL CONDITIONS FOR USE. SURGERY WAS DELAYED 5 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20168512 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY NEEDED DUE TO PERIPROSTHETIC INFECTION. DOI: (B)(6) 2021. DOE: (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 19949649 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF PAIN AND SURGEON NOTES GLOBAL INSTABILITY. ALL COMPONENTS ARE REMOVED AND A KNEE REVISION IS PERFORMED. NO DELAY OR PATIENT HARM IS NOTED. COMPONENTS ARE WELL FIXED, APPROPRIATELY SIZED IN GOOD ALIGNMENT AND JOINT LINE APPEARS APPROPRIATE. NO WEAR IS NOTED. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19361366 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS THE FIRST STAGE OF A TWO STAGE KNEE REVISION PROCEDURE DUE TO INFECTION. DURING THIS STAGE, THE PATIENT'S PRIMARY KNEE COMPONENTS WERE REMOVED AND REPLACED BY ANTIBIOTIC CEMENT SPACERS. THERE WAS NO LOOSENING. THE CEMENT MANUFACTURER WAS DEPUY. NO SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19319658 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. CAN YOU CONFIRM, IF DEPUY CEMENT WAS USED, DURING THE PRIMARY SURGERY? NO DEPUY CEMENT. C. WAS THERE ANY SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 19180575 ↗