ATTUNE 1506-80-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10603295492153), received between Jul 6, 2020 and Jun 3, 2026 — classified as 25 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (29 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, 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-1316-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CR RP INSRT SZ 4 5MM, ATTUNE CR FEM RT SZ 4 CEM, AND ATTUNE RP TIB BASE SZ 3 CEM WERE INVOLVED IN A REPORTED EVENT FOLLOWING KNEE SURGERY. THE EVENT CONCERNED A POSSIBLE ALLERGIC REACTION EXPERIENCED BY A PATIENT MORE THAN ONE YEAR AFTER IMPLANTATION OF THE ATTUNE PROSTHESIS. THE PATIENT CONSEQUENCE WAS DESCRIBED AS A POTENTIAL ALLERGIC REACTION, CLASSIFIED AS A MINOR INJURY, AND NO DEVICE MALFUNCTION WAS ALLEGED. THERE WAS NO REMOVAL OF THE IMPLANTS, AND THE DEVICES REMAIN WITH THE CUSTOMER, NOT AVAILABLE FOR RETURN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25374043 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO SURGEON IN CLINIC WITH KNEE STIFFNESS AND WAS UNABLE TO GET KNEE INTO FULL EXTENSION. SURGEON PERFORMED FULL REVISION OF PRIMARY ATTUNE IMPLANTS TO ATTUNE REVISION WITH SLEEVES ON BOTH SIDES (TIBIA AND FEMUR).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 22965776 ↗
• InjuryAug 5, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 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: THE ATTUNE FEMORAL COMPONENT AND ATTUNE TIBIAL TRAY WERE REVISED FOR LOOSENING AT AN UNKNOWN INTERFACE.

  Patient problems: Insufficient Information

  MAUDE report 22716873 ↗
• InjuryMay 7, 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 Q1 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 ARTHROFIBROSIS AND PAIN.

  Patient problems: Adhesion(s); Pain

  MAUDE report 21978590 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20871626 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL COMPONENTS WERE REMOVED EXCEPT FOR THE PATELLA. REASON FOR REVISION WAS DUE TO INSTABILITY, PARTICULARLY MID FLEXION INSTABILITY. THEY HAVE HAD BOTH SIDES DONE, BUT WERE NEVER HAPPY WITH THIS SIDE. COMPONENTS WERE ALL WELL FIXED. SURGEON NOTED THAT THE TIBIAL SLOPE DID NOT LOOK RIGHT, AND THERE WAS ALSO BONE LEFT OUT THE BACK FROM THE PRIMARY TIBIAL RESECTION WHICH WAS NOT ADEQUATELY CLEARED. THEY WERE ALSO TIGHTER IN EXTENSION RELATIVE TO FLEXION, SO WAS NOT A BALANCED KNEE. DOI: (B)(6) 2021 DOE: (B)(6) 2024.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18852251 ↗
• InjuryJan 31, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  SURGEON SAID THE PATIENT COMPLAINED OF PAIN MONTHS AFTER THEIR PRIMARY KNEE SURGERY. HE THOUGHT THEY MAY HAVE AESEPTIC LOOSENING SINCE THEY DID NOT SHOW ANY SIGNS OF INFECTION. HE REMOVED ALL COMPONENTS AND WAITED ON CULTURES TO MAKE SURE THE PATIENT WAS NOT INFECTED AND REPLACED IMPLANTS WITH ATTUNE REVISION COMPONENTS. ALL COMPONENTS SEEMED TO BE CEMENTED ON WELL. BONE AND CEMENT WERE STILL ON THE FLAT PART OF THE TIBIAL TRAY. SALES REP DID NOT OBSERVE ANY CEMENT ON THE CONE OF THE TIBIAL COMPONENT. NO ONE MENTIONED THEIR BEING ANY PROBLEMS WITH OUR IMPLANTS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18613448 ↗
• InjuryJan 29, 2024Migration; Migration

  PATIENT WAS BEING REVISED DUE TO PAIN AND STIFFNESS IN THE LEFT KNEE. IT WAS DETERMINED THE IMPLANTS WERE PUT IN SLIGHT VALGUS ALIGNMENT AND THE FEMORAL COMPONENT HAD AN AREA OF LOOSENING. BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER UNKNOWN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI - UNKNOWN. DOR - (B)(6) 2024. AFFECTED SIDE - LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18596476 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED BECAUSE OF CONSTANT KNEE PAIN. THERE WAS NO EVIDENCE OF LOOSENING OR INSTABILITY. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17731498 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT ATTUNE TKR. PATIENT EXPERIENCING PAIN, SURGEON SUSPECTED TIBIAL BASEPLATE LOOSENING, POTENTIAL EVIDENCE ON SCANS. UPON OPENING TIBIAL COMPONENT WAS NOT LOOSE. SURGEON CHOSE TO REMOVE TIBIAL COMPONENT AND PUT IN REVISION TIBIA WITH SLEEVE AND INCREASE SIZE OF POLY. FEMORAL COMPONENT AND PATELLA COMPONENT UNTOUCHED. DOI: (B)(6) 2019. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17170137 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT DEPUY CEMENT WAS USED. THERE WAS NO SURGICAL DELAY OR BROKEN INSTRUMENTS DURING THE CASE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 16896433 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PRIMARY SURGERY WAS PERFORMED VIA TKA FOR THE LEFT OA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023, TO REMOVE THE IMPLANTS, TO CLEAN THE AFFECTED AREA AND TO INSERT CEMENT MOLD, DUE TO THE DELAYED ONSET INFECTION. THE RE-REVISION SURGERY IS SCHEDULED ON AN UNKNOWN DATE WHEN THE INFECTION IS CURED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16832997 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXPLANT OF IMPLANTS BECAUSE OF INFECTION. 2 STAGE REVISION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16637828 ↗
• MalfunctionJan 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER COMPLAINED THAT A HAIR WAS INSIDE THE STERILE PACKAGING. ONE PART INSIDE AND THE OTHER PART OUTSIDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251827 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTED KNEE. DOI : (B)(6) 2022. DOR : (B)(6) 2022. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15902506 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT FREQUENT DISLOCATIONS OCCURRED AFTER THE MANUAL REDUCTION. THIS PC REPORTS THAT THE POSTERIOR DISLOCATION OCCURRED DUE TO FALL. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS OF THE KNEE JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT FELL, AND POSTERIOR DISLOCATION OCCURRED IN (B)(6) 2022. THE SURGEON PERFORMED MANUAL REDUCTION AND USED A BRACE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 15224241 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT THE POSTERIOR DISLOCATION OCCURRED DUE TO FALL. THIS PC REPORTS THAT FREQUENT DISLOCATIONS OCCURRED AFTER THE MANUAL REDUCTION. IT WAS REPORTED THAT ON UNKNOWN DATE IN (B)(6) 2022, THE PATIENT UNDERWENT MANUAL REDUCTION DUE TO POSTERIOR DISLOCATION CAUSED BY A FALL. HOWEVER, FREQUENT DISLOCATION OCCURRED. ON (B)(6) 2022, THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED THE ATTUNE CRS, THE ATTUNE FB. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Fall; Insufficient Information; Joint Laxity

  MAUDE report 15190919 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE BEING UNSTABLE IN EXTENSION. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 14039885 ↗
• MalfunctionApr 4, 2022Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE IMPLANTS IN QUESTION. THE X-RAY TAKEN IMMEDIATELY AFTER THE FIRST SURGERY SHOWED THAT THE IMPLANTS WERE PLACED IN A SLIGHTLY INVERTED POSITION. AFTER THAT, THE ALIGNMENT GRADUALLY BEGAN TO TILT, AND THE PATIENT WAS SCHEDULED TO UNDERGO REVISION SURGERY ON (B)(6) 2022. THE POSSIBILITY OF INFECTION ALSO CANNOT BE RULED OUT. IN THE REVISION SURGERY, ONLY IMPLANTS OF TIBIAL SITE WILL BE EXCHANGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 13994553 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: UNKNOWN; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13634271 ↗
• MalfunctionJan 25, 2022Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE TKA SURGERY FOR OA WITH THE TIBIAL TRAY IN QUESTION. DURING THE SURGERY, IT WAS CONFIRMED THAT THERE WERE TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY. THE TRAY WAS USED AS IT WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE ADVERSE EVENT TO THE PATIENT IS NOT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13342779 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS CAUSALLY RELATED TO DEVICE AND IS CAUSALLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA. PRE-MANIPULATION (IN DEGREES): EXTENSION: 5. HYPEREXTENSION FLEXION: 90. POST-MANIPULATION (IN DEGREES): EXTENSION: 0. HYPEREXTENSION FLEXION: 130.

  Patient problems: Adhesion(s)

  MAUDE report 13307600 ↗
• MalfunctionJan 20, 2022Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS CONFIRMED THAT THERE WERE TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY. THE TRAY WAS USED AS IT WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13306575 ↗
• MalfunctionJan 7, 2022Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS CONFIRMED THAT THERE WERE TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY. IT WAS ALSO CONFIRMED THAT THE BLISTER PACK HAD BEEN SLIPPED OUT OF PLACE. THE TRAY WAS USED AS IT WAS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE ADVERSE EVENT TO THE PATIENT IS NOT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13191816 ↗
• MalfunctionDec 29, 2021Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Off-Label Use; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  TRACES OF DIRT AND PROTECTIVE COVERS ON THE SURFACE OF THE TRAY WERE FOUND DURING SURGERY. THE TRAY WAS USED AS IT WAS. SURGICAL DELAY OF 30 MINUTES OCCURRED.

  Patient problems: Insufficient Information

  MAUDE report 13108394 ↗