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Humeral Cup Stability 312-0909Recalls & reported problems

Fx Solutions · HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +9 · Class 2 · Implant

All models of Humeral Cup Stability (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03701037310632), received between Mar 25, 2022 and Mar 25, 2022 — classified as 1 injury.

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 18, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Device Dislodged or Dislocated1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryMar 25, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

    THE PATIENT WAS REVISED ON (B)(6) 2021 FOR DISLOCATION. APPROXIMATELY 2 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP (32/9), 1 GLENOID BASEPLATE (24), 1 CENTERED GLENOSPHERE (32), 3 LOCKING SCREWS (26, 20, 15), 1 CORTICAL SCREW (24) AND 1 STANDARD SCREW (30). THE SURGEON IMPLANTED 1 OFFSET HEAD (46X18) AND 1 DOUBLE TAPER (0).

    Patient problems: Insufficient Information

    MAUDE report 13899822 ↗

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Sources and updates

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