ATTUNE 1513-22-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295043843), received between Dec 11, 2019 and May 15, 2026 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN DOING WELL AND PRESENTED IN AN OUTSIDE FACILITY WITH SUSPECTED INFECTION WHILE ON VACATION. A WOUND VAC WAS PLACED AND PATIENT RETURNED TO HIS TREATING SURGEON FOR CARE. ALL COMPONENTS WERE WELL FUNCTIONING AND WELL FIXED SO NO ALLEGATION WAS MADE AGAINST THE COMPONENTS. THERE WAS NO DELAY NOR PATIENT HARM WAS NOTED. A STATIC APACER WAS FASHIONED UTILIZING LPS COMPONENTS WITH HIGH DOSE ANTIBIOTIC CEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THIS PATIENT HAS HAD INTERVENTIONS ON THE FOLLOWING DATES WHERE IMPLANTS WERE EXCHANGED AND DERS WERE SUBMITTED. ON (B)(6) 2025, (B)(4), ON (B)(6) 2025, (B)(4). CEMENT UTILIZED WAS DEPUY 2 WITH GENT AND HOSPITAL OWNED. HIS PATELLAR COMPONENT HAD BEEN PLACED ON (B)(6) 2022 AND RETAINED FROM HIS PRIMARY TKA. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE. (B)(6) WERE CREATED FOR THE FIRST AND SECOND REVISION". ALL IMPACTED PRODUCTS IN THESE TWO PC'S ARE PART OF THE SAME THIRD REVISION SURGERY FOR ONGOING INFECTION--IN THIS THIRD REVISION ALL PRODUCTS WERE REMOVED, AND AN ANTIBIOTIC SPACER WAS IMPLANTED." THE KNEE (WITH ALL OF THE CURRENT IMPACTED PRODUCTS EXCEPT THE INSERT) WAS

  Patient problems: Unspecified Infection

  MAUDE report 25190591 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUES TO BE INFECTED. THE SPACER AND ALL CEMENT ARE REMOVED. A THOROUGH I&D IS PERFORMED AND A NEW SPACER IS FASHIONED UTILIZING LPS COMPONENTS. NO PATIENT HARM NOR DELAY WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23477210 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTINUED TO DRAIN FROM KNEE WOUND. SURGEON ELECTED TO REMOVE KNEE PROSTHESIS AND FUSE THE KNEE. THIS COMPLAINT (B)(4) IS RELATED TO (B)(4). DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22330163 ↗
• MalfunctionJun 6, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE STEM COULD NOT BE PROPERLY ATTACHED TO FEMORAL COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475640 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA TENDON RUPTURE AND INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: 04 APR 2024. (RIGHT KNEE). TREATMENT: RECONSTRUCTION OF PATELLA TENDON, I&D, INJECTED MEDICATION, AND REPEATED DAIR PROCEDURES.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 19126153 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DSJ-2016-02 CLINICAL ADVERSE EVENT RECEIVED FOR FLEXION DEFICIT AT RIGHT KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019 DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE) TREATMENT: DIAGNOSTIC INTERVENTION AND RESECTION OF HETEROTOPIC BONE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19117286 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS POSITIVE FOR NICKEL ALLERGY AND IS SYMPTOMATIC TO INCLUDE ITCHING, RASHES, AND PAIN. ALL COMPONENTS WERE REMOVED SUCCESSFULLY WITHOUT PATIENT HARM OR DELAY AND A METAL SENSITIVE KNEE REVISION WAS PERFORMED UTILIZING COMPONENTS FROM A DIFFERENT MANUFACTURER. HIS INITIAL KNEE REVISION WAS PERFORMED ON THE DATE LISTED, HOWEVER A TIBIAL SIDE REVISION WAS ALSO PERFORMED ON (B)(6) 2023 DUE TO PAIN. A DER WAS SUBMITTED AT THAT TIME. IT WAS LATER, WHEN HIS PAIN PERSISTED THAT THE METAL ALLERGY TEST WAS PERFORMED AND HIS ALLERGY WAS CONFIRMED. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Pain; Rash

  MAUDE report 18541812 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE ARTHROFIBROSIS AND LIMITED RANGE OF MOTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF EVENT: UNK (B)(6) 2021, (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 15162959 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURE THE PERIPROSTHETIC FRACTURE INCURRED AT THE TIME OF THE IMPLANTATION OF THE LONGER TIBIAL STEM. DOE: (B)(6) 2015. LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15051312 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DSJ-2016-02 NEW. CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: UNK MAY 2021. AFFECTED AREA: (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA

  Patient problems: Loss of Range of Motion

  MAUDE report 14655675 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. DATE OF IMPLANTATION - (B)(6) 2021. B. LOT NUMBER: - ATTUNE CRS FEMORAL RT SZ 7 CEM (150440207) - LOT # J8602J. - ATUNE PRESSFIT STR STEM24X60MM (151324060) - LOT # J06R66. REFER TO ADDITIONAL EVENT INFORMATION A-6001132 WHICH HAS THE USAGE FROM THE PRIMARY SURGERY. C. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. - UNKNOWN. D. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? - AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12261783 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: 2 X ERYTHROCYTE CONCENTRATE (TRANSFUSION 2 UNITS PACKED RED BLOOD CELLS).

  Patient problems: Anemia

  MAUDE report 11263896 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEFT TOTAL KNEE REVISION. THE SURGEON DID ALL THE PROPER PREPPING FOR A STEM AND SLEEVE FOR THE FEMUR. THE SURGEON OVER REAMED 1MM, AND BROACHED PROPERLY. THE TRIAL CONSTRUCT SAT PERFECTLY. DURING IMPACTION OF THE REAL FEMORAL COMPONENT, THE PATIENT'S FEMUR CRACKED/BROKE. THE IMPLANT WAS FULLY SEATED BY THE SURGEON, AND THE SURGEON PUT 2 CABLES AROUND THE FEMUR TO STABILIZE THE FRACTURE. THE PRESS FIT BETWEEN THE TRIAL BROACH AND STEM COMPARED THE REAL IMPLANT IS TOO MUCH. THIS CAUSES FRACTURES AND ENDANGERS THE PATIENT. THERE WAS A SURGICAL DELAY OF 15 MINS. DOE: (B)(6) 2020; LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10108899 ↗
• MalfunctionJan 27, 2020Inadequacy of Device Shape and/or Size; Manufacturing, Packaging or Shipping Problem; Inadequacy of Device Shape and/or Size; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE IMPLANT SEEMED TO BE MUCH LARGER THAN WHAT THE BOX INDICATED. AS A RESULT, THEY DECIDED TO GO DOWN A SIZE ON THE STEM IMPLANT. DOE: (B)(6) 2020, (RIGHT KNEE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633366 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Anemia; Discomfort; Pain

  MAUDE report 9450922 ↗