PERSONA® 42-5171-008-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024238657), received between Nov 5, 2020 and Apr 15, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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.

• MalfunctionApr 15, 2024Fracture; Fracture

  IT WAS REPORTED THE ARTICULAR PROVISIONAL SEEMS TO HAVE BROKEN IN HALF DURING EXCISION. NO DEBRIS EVER FELL NOR WAS LEFT IN PATIENT. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105793 ↗
• MalfunctionNov 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT A TASP FRACTURED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138989 ↗
• MalfunctionMar 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER SURGERY WHEN THE PIECES WERE TAKEN APART, THE BACK OF THE TASP BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665013 ↗
• MalfunctionNov 5, 2020Fracture; Fracture

  IT WAS REPORTED THAT SURGEON WAS TRIALING WITH THE LEFT MC POLY TRAIL FOR FINAL KNEE TRIAL BEFORE OPENING IMPLANTS. WHEN HE ATTEMPTED TO REMOVE THE POLY TRIAL FROM THE JOINT, THE POSTERIOR CORNER OF THE POLY TRIAL BROKE. THE PIECES WERE REMOVED AND THE CASE CONTINUED WITHOUT FURTHER INTERRUPTION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10792486 ↗