ATTUNE 1506-70-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10603295492054), received between Dec 15, 2017 and Aug 18, 2026 — classified as 59 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (14 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patients presents with poor motion and instability post primary TKA. All components were found to be well fixed and well aligned however there was significant patella baja noted. It was unknown if this was present at the time of the primary knee or developed due to lack of motion. No allegation was made against any component. No patient harm nor delay was noted. Cement was hand mixed by surgeon in an open bowl. No other information about storage, time or information was available.Cement Manufacturer was DePuy Synthes.Affected Side: Right Knee.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 50301837 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO AN INJURY THAT RESULTED IN MCL INSTABILITY REQUIRING A MORE CONSTRAINED PROSTHESIS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 25391349 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS WITH PERSISTENT PAIN AND POOR ROM POST TKA BY AN OUTSIDE SURGEON AND POLY AND PATELLA EXCHANGE ON (B)(6) 2023 BY THE TREATING SURGEON. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED. PATIENT BELIEVES SHE HAS AN ALLERGY TO NICKEL AND WELL-FIXED FEMUR, POLY AND TIBIA WERE REMOVED AND THE COMPONENTS WERE REVISED TO A COMPANY OFFERING NICKEL FREE ALTERNATIVE PROSTHESES. NO DELAY NOR PATIENT HARM IS NOTED. NO ALLEGATION IS MADE AGAINST ANY COMPONENT. PATELLA COMPONENT WAS LEFT IN PLACE FROM (B)(6) 2023 AS IT WAS WELL FIXED AND TRACKS WELL. NO LOT INFORMATION WAS AVAILABLE IN OPTIMIZE AS THIS INFORMATION WAS NOT TRANSFERRED IN THE MIGRATION FROM COMPASS TO OPTIMIZE. DOI: (B)(6) 2019, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25304193 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BILATERAL KNEE PAIN, PARTICULARLY IN THE RIGHT KNEE, FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PAIN WAS CONSIDERED TO BE DUE TO PROSTHESIS DISCOMFORT OR EXCESSIVE SUTURE TENSION AFTER JOINT REPLACEMENT. THE STITCHES WERE INTERMITTENTLY REMOVED FROM THE WOUND FOR DRESSING CHANGE TO REDUCE THE WOUND TENSION. THE PATIENT WAS GIVEN IODOPHOR SOLUTION FOR DRESSING CHANGE. PATIENT IMPROVED SIGNIFICANTLY AFTER A FEW DAYS AND WAS DISCHARGED. PRODUCT NOT EXPLANTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 24533346 ↗
• InjuryMar 5, 2026Migration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY CAUSED BY MEDIAL TIBIAL TRAY SUBSIDENCE. DR. REMOVED THE PATIENT'S ATTUNE PRIMARY INSERT, FEMUR, AND TIBIAL TRAY. DR. REPLACEMENT THEM WITH ATTUNE REVISION IMPLANTS, TO INCLUDE A MEDIAL TIBIAL AUGMENT AND PRESS-FIT STEMS. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24520918 ↗
• InjuryJan 21, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT AFTER NUMEROUS FALLS PATIENT COMPLAINT OF PAIN PROXIMAL MEDIAL TIBIA REVISION OF TIBIAL TRAY AND INSERT. LOOSENING INTERFACE WAS MARKED AS BONE TO CEMENT AND IT IS A DEPUY CEMENT. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 24129195 ↗
• InjuryDec 17, 2025Migration; Migration

  IT WAS REPORTED THAT OVER TIME, THE PATIENT'S KNEE BECAME PAINFUL AND TIBIA APPEARS TO HAVE SUBSIDED MILDLY. REVISION SURGERY WAS PERFORMED ON THE TIBIA, POLY, AND PATELLA, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23831677 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION AT 10 WEEK FOLLOW UP APPOINTMENT. KNEE WAS ASPIRATED AND CAME BACK POSITIVE FOR INFECTION. THE DOCTOR DECIDED TO EXPLANT THE TOTAL KNEE AND GAVE THE PATIENT A TEMPORARY ANTIBIOTIC SPACER UNTIL INFECTION IS CLEARED. ONCE INFECTION IS CLEARED, PATIENT WILL BE REVISED TO ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2025 , DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23301001 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION. DURING THE FIRST STAGE OF WHAT WILL BE A TWO STAGE REVISION PROCEDURE, THE PATIENT'S PRIMARY ATTUNE COMPONENTS WERE REMOVED AND REPLACED BY AN ANTIOBIOTIC SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22063813 ↗
• InjuryApr 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. UNKNOWN SURGICAL DELAY. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21926081 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 21738167 ↗
• InjuryMar 27, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT HAD SUBSIDED LOOSE TRAY. TIBIA LOOSENING OCCURRED AT BONE TO CEMENT INTERFACE. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21707872 ↗
• InjuryFeb 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A REVISION OF DEPUY IMPLANTS DUE TO ASEPTIC LOOSENING. UNKNOWN SURGICAL DELAY. THERE WAS LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21444710 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR IT BAND TENDINITIS. DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: DEFINITELY NOT, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 26/NOV/2024, DATE OF IMPLANT: NO INFORMATION PROVIDED, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT. DEPUY SYNTHES PRODUCT USED: CATALOG ID: 151820032, LOT ID: 3802592, COMPONENT TYPE: PATELLAR, DESCRIPTION: ATTUNE MEDIAL DOME PAT 32MM. CATALOG ID: 151820308, LOT ID: JP9042, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 3 8MM. CATALOG ID: 150400103, LOT ID: 8093073, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE C/RET FEM LT SZ 3 CEMENTED. CATALOG ID: 150670003, LOT ID: 9854210, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 3. CATALOG ID: 249095000, LOT ID: M0476R, COMPONENT TYPE: PIN, DESCRIPTION: AMK FIXATION PINS 1/8 DIA X 3. CATALOG ID: 950502303, LOT ID: M1312Z, COMPONENT TYPE: ACC, DESCRIPTION: SIGMA LCS HIGH PERFORMANCE, STERILE THREADED HEADED PINS. CATALOG ID: 3312040, LOT ID: 3807417, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET CMW 1 40G.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20903575 ↗
• InjuryOct 28, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20544261 ↗
• MalfunctionOct 11, 2024Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material; Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT PATIENT UNDERWENT AN KNEE SURGERY ON (B)(6) 2024. TWO UNITS OF TIBIAL BASE WERE OPENED AND IN BOTH CASES THE SECONDARY PACKAGING WAS IN POOR CONDITION. ANOTHER IMPLANT WAS OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN EIGHT MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427178 ↗
• MalfunctionOct 11, 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 PATIENT UNDERWENT AN KNEE SURGERY ON (B)(6) 2024. TWO UNITS OF TIBIAL BASE WERE OPENED AND, IN BOTH CASES, THE SECONDARY PACKAGING WAS IN POOR CONDITION. ANOTHER IMPLANT WAS OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN EIGHT MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426953 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND KNEE BECAME UNSTABLE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Joint Laxity

  MAUDE report 20345160 ↗
• InjurySep 10, 2024Migration; Migration

  PATIENT WAS REVISED DUE TO SUBSIDENCE. DOI: UNKNOWN. DOR: (B)(4) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20185169 ↗
• InjuryAug 28, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT WAS REVISED DUE TO TIBIAL IMPLANT SUBSIDENCE AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20085351 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6), 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19742286 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19472113 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INFECTION, PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19168702 ↗
• InjuryMar 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  S+ TIBIAL BASE PLATE LOOSENING, WHICH LEAD TO THE SURGEON HAVING TO REVISE TO AN ATTUNE REVISION TIBIA. LOOSENING OF THE BASE PLATE CAUSED VARUS KNEE TO OCCUR.

  Patient problems: Insufficient Information

  MAUDE report 18988374 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: INSTABILITY AND BONE FRACTURE.

  Patient problems: Joint Laxity

  MAUDE report 18963061 ↗