ATTUNE 1516-40-910Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295050520), received between Oct 19, 2017 and Nov 4, 2022 — classified as 2 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS DRAINING SO SURGEON PERFORMED AN I&D AND DID A POLY SWAP. POLY IS NOT BEING RETURNED. AND NO OTHER INFORMATION IS AVAILABLE. DOI : (B)(6) 2022, DOR; (B)(6) 2022, AFFECTED SIDE : UNKNOWN.

  Patient problems: Fluid Discharge

  MAUDE report 15734431 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 26 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL RIGHT KNEE ARTHROPLASTY DUE TO DEGENERATIVE OSTEOARTHRITIS AND PAIN. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO DECREASED RANGE OF MOTION, AND REMOVAL OF HETEROTOPIC CALCIFICATION TO FEMUR, AND POLYETHYLENE EXCHANGE. THE SURGEON REPORTED A LARGE HETEROTOPIC BONE IN THE QUADRICEPS TENDON AND MUSCLE ON ANTERIOR SURFACE TO THE FEMUR WHICH WAS DEBRIDED AND REMOVED. THE SURGEON INDICATED HE DEBRIDED THE KNEE OF SCAR TISSUE AND REMOVED THE POLYETHYLENE COMPONENT WITH DEBRIDEMENT. THE PATIENT WAS IMPLANTED WITH DEPUY INSERT, AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016; DOR: (B)(6) 2016 (RT KNEE).

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9215746 ↗
• MalfunctionOct 19, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  EVENT INFORMATION STATES THAT POLY WOULD NOT SEAT INTO THE TIBIAL TRAY.

  Patient problems: No Information

  MAUDE report 6961451 ↗

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