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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-01-03Z-1216-2024Class IIOpen, ClassifiedTheir is a potential that the implant curved stem may be oriented incorrectly.Distribution: US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwan479 unitscode info di
2024-01-03Z-1217-2024Class IIOpen, ClassifiedTheir is a potential that the implant curved stem may be oriented incorrectly.Distribution: US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom, Malaysia, Philippines, Taiwancode info di
Regulatory clearances

    Predicate lineage

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2026-03-12VAIVoluntary action indicatedUnited Orthopedic Corp.0
    2026-03-12VAIVoluntary action indicatedUnited Orthopedic Corp.0
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