PyroCarbon PIP Total Joint System PIP-200-40P-WWRecalls & reported problems
Smith & Nephew, Inc. · PIP SZ. 40 PROXIMAL · Class f · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556858462), received between Sep 22, 2025 and Sep 22, 2025 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A PYROCARBON PIP REPLACEMENT SURGERY, IT WAS NOTICED THAT WHILE IMPLANTING ONE (1) PIP SZ. 40 PROXIMAL, THE IMPLANT FAILED, BREAKING THE DISTAL HEAD AND LEAVING THE STEM IMPLANTED IN THE PROXIMAL BONE. THE SURGEON USED A FREER TO REMOVE A LARGE PORTION; THE REMAINING PART WAS BURRED OUT WITHOUT COMPLICATION, AND THE WOUND WAS COPIOUSLY IRRIGATED. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY OF 30 MINUTES, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23106770 ↗
Other High demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis devices
- PyroCarbon PIP Total Joint System PIP-200-10P-WWSmith & Nephew, Inc. · High demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis2 reports
- PyroCarbon PIP Total Joint System PIP-200-20P-WWSmith & Nephew, Inc. · High demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis1 report
- PyroCarbon PIP Total Joint System PIP-200-30P-WWSmith & Nephew, Inc. · High demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis1 report
- Ascension PIP PIP-200-20P-WWAscension Orthopedics, Inc. · High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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