Series 7000 7291-0110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540117038), received between Oct 16, 2019 and Oct 16, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 other recall cover devices cleared under the same FDA submission (K914565); 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.

• InjuryOct 16, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POLY WEAR. A POLY EXCHANGE WAS PERFORMED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9197363 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K914565. One submission often covers many models, so check the product and lot details in each record.

• Z-0926-2024 · Dec 1, 2023 · Open, Classified
  TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324