Identity Imprint Knee Replacement System TCR000D00201Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M572TCR000D002011), received between Nov 24, 2021 and Nov 24, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

1 other recall cover devices cleared under the same FDA submission (K210191); 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.

• InjuryNov 24, 2021Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON NOTICED A HOLE IN BOTH THE INNER AND OUTER POUCHES FOR THE TIBIAL TRAY, POTENTIALLY COMPROMISING STERILITY. THERE WAS A MAJOR DELAY OF MORE THAN ONE HOUR TO RESTERILISE THE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 12872434 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K210191. One submission often covers many models, so check the product and lot details in each record.

• Z-1591-2024 · Mar 11, 2024 · Open, Classified
  Identity Imprint PS Tibial Tray Size 4: Lot 540287