emField 5038Recalls & reported problems
Zimmer MedizinSysteme GmbH · Class 2
- 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 04053815078562), received between Mar 14, 2024 and Mar 14, 2024 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2024Fracture; Fracture
THE DEVICE HAS BEEN USED WITH A KNOWN DEFECTIVE SPHERICAL JOINT IN THE APPLICATOR ARM. THE JOINT BROKE, THE APPLICATOR FELL DOWN AND THE ARM BOUNCED UP THROUGH THE FORCE OF A GAS PRESSURE SPRING. A BYSTANDER WAS HIT BY THE ARM AND RECEIVED A LACERATION AT THE FOREHEAD. THE WOUND HAS TO BE STITCHED.
Patient problems: Laceration(s)
MAUDE report 18902515 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.