GENESIS 71243619Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010501738), received between Nov 3, 2018 and Nov 3, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K230653, K912735); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

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

• InjuryNov 3, 2018Break; Break

  IT WAS REPORTED THAT AFTER PROCEDURE, A BROKEN METALLIC RING WAS DISCOVERED INSIDE PATIENT. NO REMEDIAL ACTION REPORTED. NO PROCEDURE, DELAY, INJURY OR BACK UP REPORTED.

  Patient problems: Injury

  MAUDE report 8036164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K230653, K912735. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-0304-05 · Jun 21, 2004 · Terminated
  Genesis Uni Articular Inserts
• Z-0305-05 · Jun 21, 2004 · Terminated
  Tibial Base Plates