Ascension MCP Joint Replacement MCP-100-10P-WWRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556856727), received between Nov 20, 2023 and Nov 20, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (P000057); 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.

• MalfunctionNov 20, 2023Fracture; Malposition of Device; Migration; Fracture; Malposition of Device; Migration

  IT WAS REPORTED THAT DURING A MCP JOINT REPLACEMENT SURGERY, AFTER IMPACTING THE PROXIMAL COMPONENT OF THE MCP SZ. 10 PROXIMAL WW, IT WAS FOUND TO HAVE ROTATED IN THE CANAL. SURGEON DECIDED TO REMOVE AND REPOSITION THE IMPLANT. UPON USING THE MCP IMPLANT EXTRACTOR TOOL AND PULLING THE IMPLANT OUT BY WRAPPING FIBRETAPE AROUND THE TOP OF THE STEM, THE IMPLANT STEM BROKE IN TWO, LEAVING THE TIP OF THE STEM INSIDE THE CANAL. THE BROKEN IMPLANT WAS REMOVED BY LOOSENING WITH K-WIRES AND SALINE WASH. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. NO PICTURES NOR X-RAYS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171953 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000057. One submission often covers many models, so check the product and lot details in each record.

• Z-0550-03 · Oct 31, 2002 · Terminated
  Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal