ATTUNE 1516-41-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295050643), received between Sep 14, 2018 and Mar 24, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 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 PAIN. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21678756 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR SLIGHT INSTABILITY IN EARLY FLEXION. SURGEON CONFIRMED FIXATION OF FEMUR AND TIBIA PROSTHESIS; NO ASEPTIC LOOSENING PRESENT. ATTUNE LINER REPLACED. DOI: (B)(6) 2018. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9398324 ↗
• InjuryOct 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 26 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. 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) 2018, THE PATIENT UNDERWENT LEFT KNEE REVISION DUE TO INFECTION AND DISLOCATED POLYETHYLENE INSERT. THE SURGEON REPORTED ELEVATED CRP AND RATE 4.03 AND 43 RESPECTIVELY IN THE PREVIOUS MONTH. HE REPORTED CULTURE (B)(6) OF (B)(6). THE SURGEON ALSO NOTED CONSISTENT DRAINAGE THE 10 DAYS PRE-SURGERY. HE INDICATED PRIOR TO ENTERING THE KNEE, THE KNEE WAS ASPIRATED, AND GROSS PUSS WAS ENCOUNTERED AND SENT TO LAB. THERE WERE NO LAB RESULTS INCLUDED IN THE PATIENT¿S RECORDS. THE SURGEON REPORTED AN AGGRESSIVE SYNOVECTOMY WHERE THE TIBIAL INSERT WAS FOUND DISASSOCIATED FROM THE TIBIAL PLATE. HE REPORTED THE TIBIAL AND FEMORAL COMPONENTS WERE WELL-FIXED THOUGH REVISED. THE PATELLA WAS REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2016 . DOR: (B)(6) 2018 (LT KNEE

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9202682 ↗
• MalfunctionSep 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN EXPIRED ATTUNE SZ 10X7 PS FB INSERT WAS IMPLANTED. THE SURGEON WAS MADE AWARE THAT THIS SPECIFIC INSERT WAS EXPIRED PRIOR TO SURGERY. DUE TO BACK ORDERS, NO REPLACEMENT WAS AVAILABLE. AN INTRA-OPERATIVE DECISION WAS MADE BY THE PHYSICIAN TO RETRIEVE AND IMPLANT THE EXPIRED DEVICE UPON HIS ORDERS. DOE: (B)(6) 2018; UNKNOWN SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877584 ↗

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