NA MCPX-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886385025391), received between Nov 3, 2020 and Nov 11, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 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.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  COMPLAINT - NOT SURE IF IT WAS FLEX OR STRAIGHT AND DOCTOR THINKS IT WAS SIZE 50. IT WAS PUT IN BY ANOTHER DOCTOR BUT THE IMPLANT WAS BROKEN WHEN REMOVED FROM THIS PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 23528609 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION TOOK PLACE DUE TO RECURRENCE OF DEFORMITY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15360744 ↗
• InjuryFeb 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED: "THE IMPLANT HAD CAME OUT DISTALLY FROM THE FLANGE CANAL. A REVISION SURGERY WAS PERFORMED."

  Patient problems: Failure of Implant

  MAUDE report 13523232 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM (B)(6), IN FRANCE. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF DEGENERATIVE OR POST-TRAUMATIC DISABILITIES IN THE METACARPOPHALANGEAL (MCP) AND PROXIMAL INTERPHALANGEAL (PIP) JOINTS WITH THE SILICONE AND PREFLEX PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SILICONE PIP AND PREFLEX MCP¿ PROSTHESIS. THIS STUDY INCLUDES RESEARCH DONE ON 109 PATIENTS (142 IMPLANTS) REQUIRING SURGERY BETWEEN THE PERIOD 2007 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES BAD JOINT STABILITY AND ULNAR OFF-AXIS.

  Patient problems: Joint Laxity

  MAUDE report 10779168 ↗