ATTUNE 1506-11-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295416258), received between Oct 23, 2018 and Aug 4, 2026 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (6 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Osseointegration Problem

  It was reported that there was loosening of the press fit tibia.DOI - On (b)(6) 2021.DOR - On (b)(6) 2026.Affected side- Left Knee.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50133517 ↗
• InjuryMay 6, 2026Migration

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT TOTAL KNEE. HER KNEE HAD A VALGUS DEFORMITY. THE SURGEON PUT HER IN A MORE NEUTRAL ALIGNMENT AND USED PRESSFIT IMPLANTS. SHE NOW HAS A TIBIAL TRAY THAT HAS FALLEN INTO 11 DEGREES OF VARUS. THIS IS BELIEVED TO BE DUE TO THE SOFTER MEDIAL BONE ON HER TIBIA DUE TO HER ORIGINAL VALGUS DEFORMITY. SO THE SURGEON REVISED THE TIBIAL TRAY. THE FEMUR AND PATELLA ARE WELL FIXED AND RETAINED. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25092571 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) SCHOOL OF ENGINEERING AT (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 PAIN. AT REMOVAL THERE WAS MINOR YELLOWING OF THE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 21979074 ↗
• InjuryMar 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS POSTOPERATIVE TIBIA LOOSENING OF THE ATTUNE PS RP LEFT CEMENTED. IT WAS DECIDED TO CHANGE THE FEMUR AND INSERT, TOO.

  Patient problems: Insufficient Information

  MAUDE report 21618243 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN IN THE LEFT TIBIA. TIBIA INSERT WAS CHANGED AND PATELLA WAS RESURFACED.

  Patient problems: Pain

  MAUDE report 21344910 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD REVISION RTKA. PATIENT FELL SEVERAL MONTHS AGO AND HAS PAINFUL KNEE. THE TIBIA IMPLANT WAS COMPACTED DOWN MEDICALLY. REMOVED THE FEMORAL IMPLANT, TIBIAL IMPLANT AND INSERT. REVISED WITH ATTUNE REVISION KNEE SYSTEM. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Fall; Pain; Unspecified Tissue Injury

  MAUDE report 20200522 ↗
• MalfunctionJun 19, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN OPENED A TIBIAL BASE TRAY NEW IN THE BOX. SCRUB TECH NOTICED A HAIR LIKE PIECE INSIDE THE STERILE PACKAGING. HANDED IMPLANT BACK AND A NEW TIBIAL IMPLANT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 19566601 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AND FRACTURED HER TIBIA PLATEAU. THE SURGEON REMOVED THE TIBIAL AND WENT BACK WITH REVISION COMPONENTS. NO DELAY AND. NO HARM TO PATIENT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 19267978 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REVISED A PRIMARY TKR HE DID SEVERAL DAYS AGO AS THE PATIENT FELL IN THE HOSPITAL WARD AND HAD A PERI PROSTHETIC TIBIAL FRACTURE. PT WAS REVISED WITH ATTUNE REVISION TIBIAL COMPONENT WITH STEM AND SLEEVE. PT HAD GOOD FIXATION WITH REVISION IMPLANTS. FEMORAL IMPLANT WAS UNTOUCHED. POLY WAS UPSIZED. GOOD RESULT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 18836460 ↗
• InjuryFeb 23, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA FOR THE KNEE JOINT. DURING SURGERY, THE PRODUCT IN QUESTION (ATTUNE RP TIBIAL TRAY) WAS ACCIDENTALLY OPENED WHEN THE ATTUNE FB TIBIAL TRAY SHOULD HAVE BEEN OPENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18768489 ↗
• InjuryDec 20, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE RP PRESSFIT TRAY WAS REVISED FOR LOOSENING. THERE WAS LOOSENING OF THE TIBIAL TRAY. THE LOOSENING INTERFACE WAS NON CEMENTED. DEPUY CEMENT WAS USED. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18364757 ↗
• InjuryNov 8, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN IN KNEE. BONE SCAN SHOWED POSSIBLE LOOSENING OF TIBIA AND FEMUR AT THE NON CEMENTED INTERFACE. PATIENT WAS REVISED TO CRS CONSTRUCT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020; DIR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18093543 ↗
• InjuryNov 3, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT PRIMARY SURGERY WITH THE PRODUCT IN QUESTION. ON AN UNKNOWN DATE, THERE WAS EVIDENCE OF A FRACTURE AT THE REAR MEDIAL SIDE OF THE TIBIA, AND SEVERAL MILLIMETERS OF SUBSIDENCE WAS CONFIRMED. THE SURGEON WILL MONITOR THE SITUATION TEMPORARILY, BUT HE ALSO MENTIONED THAT REVISION SURGERY MAY BE NECESSARY. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION: THE REVISION SURGERY WILL BE PERFORMED FOR (B)(6) 2023. IN THE REVISION SURGERY, THE INSERT AND TIBIA WILL BE REMOVED AND A REV.RP TRAY AND PS X RP INSERT WILL BE USED.

  Patient problems: Bone Fracture(s)

  MAUDE report 18066701 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIBIAL COMPONENT REVISION DUE TO PAIN. PRESSFIT TIBIA WAS REMOVED AND REPLACED WITH A STRYKER CONE AND ATTUNE FB REVISION TIBIA AND CEMENTED STEM CONSTRUCT. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16094680 ↗
• InjuryOct 19, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY FOR OA VIA TKA WITH THE ATTUNE CS CEMENTLESS IMPLANTS IN QUESTION ABOUT 3YEARS AGO. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, IT WAS CONFIRMED ON AN UNKNOWN DATE, THAT BOTH THE KNEE FEMORAL IMPLANT (UNK) AND THE TIBIA IMPLANT (UNK) HAS LOOSENING. A REVISION SURGERY WILL BE PERFORMED. THE DATE IS UNDECIDED YET. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15632249 ↗
• InjuryMay 20, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  PRIMARY SURGERY(B)(6) 2021. REVISION OF IMPLANT (B)(6) 2022 (LEFT SIDE) REVISION OF A LOOSE AND SUBSIDED ATTUNE RP TIBIAL BASE SIZE 3 PROCOAT. REVISED TO AN ATTUNE TIBIAL TRAY WITH A METAPHYSEAL SLEEVE AND STEAM ATTUNE PS FEMUR WAS RETAINED ATTUNE PS/RP INSERT WAS CHANGED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14453457 ↗
• InjuryApr 13, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSE TIBIAL CEMENTLESS COMPONENT REMOVED AND REPLACED WITH A CEMENTED ATTUNE REVISION CONSTRUCT. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14107917 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LARGE MEDIAL HEMATOMA ON LEFT KNEE AT INCISION SITE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF EVENT (ONSET): (B)(6) 2017 (LEFT KNEE). TREATMENT: MEDICAL INTERVENTION/MODIFICATION: SURGICAL ASPIRATION AND EVACUATION OF HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 14014758 ↗
• InjuryDec 9, 2021Migration; Migration

  PATIENT WAS REVISED DUE TO TIBIA SUBSIDED AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. PATIENT KNEE WAS DONE BY A SURGEON LAST (B)(6) 2021 AT (B)(6). SURGEON WANTED TO REVISED THE ENTIRE KNEE. SINCE THE KNEE WAS DONE LESS THAN A COUPLE WEEKS, THERE WASN'T MUCH BONE INGROWTH INTO THE POROUS COMPONENTS. THE TIBIA, FEMUR, AND INSERT WERE REMOVED, LEAVING THE PATELLA IMPLANTED. THE PATIENT WAS THEN PREPPED FOR A STEM AND SLEEVE ON THE TIBIAL SIDE, AND CRS FEMUR ON THE FEMORAL SIDE. TRIAL REDUCTION WAS PERFORMED WITH A 10MM CRS INSERT AND FOUND TO BE STABLE. IMPLANTS WERE OPENED AND INSERTED. CLOSING PROCESS BEGAN. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12967101 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CHEST X-RAY RESULT RIGHT LOWER ZONE MEDICALLY. TREAT AS A RESPIRATORY TRACT INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: COMMENCED ON IV ANTIBIOTICS.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10567788 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 BY IMPLANTING THE FEMORAL COMPONENT, THE TIBIAL TRAY, THE TIBIAL INSERT FOR THE PATIENT¿S LEFT KNEE JOINT. AFTER THE SURGERY, THE PATIENT SPRAINED HER ANKLE JOINT ON (B)(6) 2020 (THIS EVENT WAS REPORTED AS (B)(4)). IT WAS REPORTED THAT THE PATIENT HAD CHEST PAIN ON (B)(6) 2019, AND SHE WAS ADVISED EXAM BY PRIMARY CARE DOCTOR. THEN, SHE UNDERWENT CAG UNDER HOSPITALIZATION ON (B)(6) 2020 AT (B)(6) HOSPITAL, AND SHE WAS ADMITTED INTO THE HOSPITAL FROM (B)(6) 2020 TO (B)(6) 2020. SHE HAS NO SYMPTOM NOW AND IS IN TREATMENT WITH MEDICATION.

  Patient problems: Chest Pain; No Code Available

  MAUDE report 10393276 ↗
• InjuryJul 30, 2019Unintended Movement; Unintended Movement

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR COLLAPSE OF THE TIBIAL METAPHYSEAL BONE WITH INCREASED SLOPE OF THE TIBIAL COMPONENT AND POSTERIOR SUBLUXATION OF THE FEMORAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017; DATE OF EVENT (ONSET): (B)(6) 2018; (LEFT KNEE).

  Patient problems: Failure of Implant

  MAUDE report 8842899 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE CEMENTLESS IMPLANTS WERE REMOVED BECAUSE OF INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8578226 ↗
• InjuryMar 18, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN, DISCOMFORT AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. THE X-RAYS SHOWED SLIGHT RADIOLUCENCY ON THE TIBIAL COMPONENT. THE SURGEON OPENED UP THE KNEE AND SAW A BIT OF MICRO MOTION SO THE POLY AND TIBIA WERE REPLACED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Discomfort; Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8429548 ↗
• MalfunctionJan 11, 2019Migration; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR COLLAPSE OF THE TIBIAL METAPHYSEAL BONE WITH INCREASED SLOPE OF THE TIBIAL COMPONENT AND POSTERIOR SUBLUXATION OF THE FEMORAL COMPONENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8242055 ↗