Identity Imprint Knee Replacement System TPS000D00201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M572TPS000D002011), received between Mar 18, 2022 and Apr 14, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2022Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE F4 JIGS FOR TWO IMPRINT CASES WERE SWAPPED - A SIZE 5 RIGHT WITH A SIZE 3 LEFT. THIS ERROR WAS DISCOVERED INTRA-OPERATIVELY FOR SN (B)(4) (SIZE 5 R CASE; SIZE 3 L SHIPPED). THE SURGEON DID NOT REALISE THEY HAD THE INCORRECT F4 UNTIL COMPLETING THE RESECTIONS. AS A RESULT, THE RESECTIONS HAD TO BE MANUALLY CORRECTED TO FIT THE IMPLANT. THERE WAS A MAJOR DELAY OF MORE THAN 20 MINUTES AS A RESULT OF THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 14115914 ↗
• InjuryMar 18, 2022Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE INCORRECT STANDARD JIGS WERE SHIPPED TO THE SURGEON. THIS WAS DISCOVERED AFTER THE SURGEON'S DISTAL FEMUR AND PROXIMAL TIBIA RESECTIONS WERE MADE WITH THE PATIENT SPECIFIC JIGS. THE SURGEON SWAPPED TO A DEPUY KNEE TO BE ABLE TO COMPLETE THE SURGERY. THERE WAS A MAJOR DELAY OF MORE THAN 20 MINUTES AS A RESULT OF THIS INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 13807400 ↗

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