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X-Change 0942-8-050Recalls & reported problems

Howmedica Osteonics Corp. · RIM MESH · Class 2 · Implant

All models of X-Change (2)

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 04546540167743), received between Nov 26, 2018 and Nov 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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

Device problems

  • Packaging Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 26, 2018Packaging Problem; Packaging Problem

    IT WAS REPORTED THAT THE SEALING LINE(AREA) OF STERILE POUCH WAS DISCOLORED, IT WAS SEEMED DIRTY, THEREFORE IT WAS CHANGED TO OTHER ONE AND PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION RECEIVED: THE STORAGE CONDITIONS IN THE ROOM WHERE THE TEMPERATURE IS CONTROLLED, THE HUMIDITY ISN¿T CONTROLLED. THE STERILE BARRIER WAS SEEMED TO KEEP, BECAUSE THE SEALING LINE WASN¿T OPENED. DISCOLORATION SEEMED A BROWN. DEVICE WAS STORED OUT OF BOX.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8103886 ↗

Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices

All Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices →

Sources and updates

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