ATTUNE 1516-40-514Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295049982), received between Jul 10, 2017 and Mar 26, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (1 report).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POLY SWAP FOR INFECTION. THEY COULD NOT READ THE LOT NUMBER ON THE POLY. NO ADVERSE EVENT OR FAILURE OF IMPLANT. THERE WAS NO CASE DELAY. NO BROKEN PIECES. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 21699975 ↗
• InjuryOct 10, 2023Naturally Worn; Naturally Worn

  STUDY NO: DOTS . CLINICAL ADVERSE EVENT RECEIVED FOR POLY FAILURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023 (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 17909562 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16760776 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO MCL DEFICIENCY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16742175 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION, POLY WAS EXCHANGED. NOTHING FURTHER TO REPORT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15632323 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR AN INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13044104 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERSISTENT DRAINAGE AND CONFIRMED INFECTION. WASH OUT WITH POLY EXCHANGE. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11917221 ↗
• MalfunctionSep 28, 2020Expiration Date Error; Expiration Date Error

  A EXPIRED PRODUCT DATE WAS USED ON THE PATIENT. CONSIGNED PRODUCT, WAS NOT SENT EXPIRED, EXPIRED IN HOSPITAL. PRODUCT: 151640514, BATCH: 596202. PRODUCT EXPIRED ON 10/2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10594127 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT MANUFACTURER. TIBIA WAS GROSSLY LOOSE AND CAME OUT CLEAN. EVERYTHING WAS REVISED EXCEPT FOR PATELLA. DOI: (B)(6) 2016; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Injury; No Code Available; Osteolysis

  MAUDE report 9520161 ↗
• InjuryJul 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6698959 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507