ATTUNE 1506-80-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 10603295492177), received between Feb 1, 2019 and Jun 4, 2026 — classified as 80 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. 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-1316-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Use of Device Problem

  IT WAS REPORTED THAT AFTER JUST COMPLETING A TOTAL KNEE, THE DOCTOR DECIDED THE TIBIAL TRAY WAS NOT PERFECTLY POSITIONED AND DECIDED TO REMOVE AND REPLACE IT. AFFECTED SIDE: LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394610 ↗
• InjuryDec 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (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 PAIN AND "SLIGHTLY LOOSE" FEMORAL COMPONENT AND TIBIAL BASE. THE NON-ARTICULAR SURFACE OF THE CEMENTED CC FEMORAL COMPONENT SHOWS ABUNDANT CEMENT REMAINING, AND NO RELATIVE MOTION. THE NON-ARTICULAR SURFACE OF THE CEMENTED TIBIAL TRAY SHOWS SPARSE CEMENT REMAINING, NO RELATIVE MOTION, AND NO IN VIVO DAMAGE.

  Patient problems: Pain

  MAUDE report 23924091 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE PS FEM RT SZ 6 NAR CEM, ATTUNE RP TIB BASE SZ 5 CEM, ATTUNE MEDIAL ANAT PAT 35MM, AND ATTUNE PS RP INSRT SZ6 5MM WERE INVOLVED IN A REVISION OF AN ATTUNE KNEE SYSTEM DUE TO PERSISTENT PAIN FOLLOWING THE INITIAL PROCEDURE. ALTHOUGH TESTS FOR INFECTION AND LOOSENING WERE NEGATIVE, ELEVATED BLOOD MARKERS LED CLINICIANS TO TREAT THE CASE AS AN INFECTION, RESULTING IN A TWO-STAGE REVISION WHERE ALL COMPONENTS WERE EXPLANTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23819041 ↗
• InjuryOct 17, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THE IMPLANTS WAS DISCARDED AFTER SONICATION .IT IS NOT POSSIBLE TO HAVE THE IMPLANTS BACK. ON THIS CASE THAT HAVE NO SENSE THE BONE WAS THE PROBLEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 23327947 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON SEPTEMBER 15, 2025; ATTUNE CR RP 3 MONTH. ALLERGY AFTER 3 MONTHS GENTAMICIN CHROM.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23203221 ↗
• InjuryAug 26, 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 PREVIOUS INFECTION AND UNEXPLAINED PAIN. A POLY EXCHANGED WAS PERFORMED. A FULL REVISION WAS DONE AND FULL DEBRIDEMENT PERFORMED PRIOR TO IMPLANTATION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22897418 ↗
• InjuryAug 5, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD ANTERIOR HALF OF IMPLANT DEBONED FROM CEMENT. POSTERIOR WAS WELL FIXED TO IMPLANT. LOOSED AT BONE CEMENT INTERFACE. THERE WAS TIBIAL PLATE LOOSENING AT BONE/CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22715036 ↗
• MalfunctionJul 25, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE IMPLANT WAS FOUND IN REP ROOM WITH PIERCED PLASTIC AND CARDBOARD BOX/POSSIBLY PIERCED IMPLANT CONTAINER. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610156 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON IS REVISING DUE TO KNEE PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22321696 ↗
• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? LIGAMENTOUS INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 22089277 ↗
• InjuryMay 15, 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 INFECTION. ATTUNE LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 22026158 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENTS RECEIVED FOR ADHESIONS DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: REMOTE POSSIBILITY PROCEDURE RELATED: PROBABLY DATE OF EVENT: 15/DEC/2024 DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 21600055 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED FOR INSTABILITY. NO HARM TO PATIENT. NO DELAYS. NO BROKEN INSTRUMENTS. DOI- (B)(6) 2019, DOR- (B)(6) 2024, AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21113140 ↗
• InjuryJan 6, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED TIBIAL SUBSIDENCE AND LOOSENING REQUIRING REVISION OF ALL ATTUNE IMPLANTS TO ATTUNE REVISION IN A SINGLE STAGE REVISION PROCEDURE. THE CEMENT THAT WAS USED WAS CMW2, 2 SEPARATE MIXES FOR TIBIA THEN FEMUR. ALL IMPLANTS REMOVED; MULTIPLE TISSUE SAMPLES TAKEN. PATIENT THEN REPREPPED AND DRAPED AND DEFINITIVE REVISION PROCEDURE CARRIED OUT.

  Patient problems: Insufficient Information

  MAUDE report 21078447 ↗
• InjuryDec 30, 2024Adverse 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 Q4 OF 2024. (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 INFECTION AND INSTABILITY. THE TIBIAL INSERT SHOWED POSTERIOR IMPINGEMENT AT REVISION.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 21034936 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE KNEE TIBIAL POLY DISLOCATION. ADDITIONAL EVENT INFORMATION: NO SURGICAL DELAY. NO ALLEGATION AGAINST THE FEMORAL COMPONENT. ORIGINAL IMPLANTATION DATE 11/10. RIGHT SIDE. THE TIBIAL INSERT SPUN OUT DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 20558768 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND THE DEVICE WAS EXPLANTED AND SPACER WAS PLACED DUE TO SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM THE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19817045 ↗
• InjuryJul 2, 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: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19657359 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 19615759 ↗
• InjuryJun 21, 2024Migration; Migration

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE BONE/CEMENT INTERFACE. THE TIBIA WAS ALSO SUBSIDED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19584520 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE I&D WAS ALSO DUE TO THE SAME STRAIN OF STAPH AS WAS FOUND ON THE (B)(6) 2024 STAGE 1 REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19483713 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO KNEE INFECTION, SURGEON EXPLANTED COMPONENTS AND REVISING WITH TEMPORARY SPACER. THERE WAS NO LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19312645 ↗
• InjuryMay 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED WITH PAIN. X-RAYS SHOWED LUCENCY BENEATH TIBIA. TRAY FOUND TO BE LOOSE. TIBIA REVISED UNEVENTFULLY WITH NO DELAY OR PATIENT HARM. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19271315 ↗
• InjuryApr 9, 2024Use of Device Problem; Use of Device Problem

  ATTUNE PS RP RIGHT PLANNING WAS CHANGED; THE TIBIA ONLY TIBIA MAL POSITION INTERNAL ROTATION. WE HAVE TO REMOVE ALL THE PROTHESIS BECAUSE IT WAS IMPOSSIBLE TO HAVE AN ATTUNE REVISION FOR THIS CASE.

  Patient problems: Insufficient Information

  MAUDE report 19071916 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18926770 ↗