PyroCarbon PIP Total Joint System PIP-200-10P-WWRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556858400), received between May 8, 2023 and Jan 3, 2025 — classified as 1 injury, 1 malfunction.

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

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.

• MalfunctionJan 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PIP REPLACEMENT SURGERY, WHILE IMPACTING THE PROXIMAL COMPONENT OF THE PIP SZ. 10 PROXIMAL INTO THE BROACHED CANAL, THE IMPLANT SNAPPED IN TWO, SEPARATING THE STEM FROM THE HEAD. THE STEM WAS LODGED IN THE CANAL, WHICH HAD TO BE BURRED OUT BEFORE REPLACING WITH ANOTHER PROXIMAL COMPONENT. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE IN THE ORIGINAL HOLE. SURGEON WAS HAPPY WITH THE SECOND IMPLANT AND THE RESULT WAS UNAFFECTED. THE STATUS OF THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066321 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A PIP ARTHROPLASTY HAD TO BE REVISED, ON (B)(6) 2023, SINCE THE JOINT DISLOCATED, AFTER BEING INITIALLY OPERATED ON (B)(6) 2023. THE REVISION SURGERY WAS MADE WITH 20P AND 20D SIZE IMPLANTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 16889706 ↗