ATTUNE 1516-40-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295050292), received between Jan 4, 2018 and Jan 4, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2018Fitting Problem; Connection Problem; Fitting Problem; Connection Problem

  DER STATES FOR HEMARTHROSIS OF KNEE; SURGEON QUESTIONED WHETHER JOINT WAS INFECTED. CULTURES SENT IN BUT STILL AWAITING RESULTS AS OF 15:00 ON (B)(6) 2017. FEMORAL COMPONENT SUSPECTED TO BE LOOSE. SURGEON EXPLANTED FEMUR, POLY AND TRAY REVISING WITH ATTUNE REVISION SYSTEM. IT WAS ALSO REPORTED THAT THE FEMUR WAS LOOSE AT THE BONE/CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. ADDITIONALLY, SURGEON WAS UNABLE TO SEAT FINAL POLY INSERT. THE POSTERIOR ASPECT OF THE POLY SAT FLUSH WITH THE TRAY BUT FELT THAT ANTERIOR ASPECT NEVER SEATED. HE REQUESTED THE PRODUCT BE SENT BACK TO INVESTIGATE. DOI: (B)(6) 2017 DOR: (B)(6) 2017 RIGHT KNEE SURGICAL DELAY OF 6 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163639 ↗

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