GENESIS 71243308Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010501547), received between Sep 13, 2018 and Sep 13, 2018 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (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.

• InjurySep 13, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE IMPLANT HAS BEEN CHECKED AT ITS REMOVAL FROM THE PACKAGING. IT WAS A MEDIUM IMPLANT OF 8 MM. IT HAS BEEN CEMENTED ON THE PATIENT BUT WAS NOT ADAPTED TO THE PATIENT. EXPLANTATION OF THE IMPLANT BECAUSE ITS SIZE WAS NOT MEDIUM COMPARED TO THE TRIAL IMPLANT BUT LARGE. USE OF A BACKUP IMPLANT.

  Patient problems: No Information

  MAUDE report 7875133 ↗

Recalls under the same FDA submission

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

• Z-0305-05 · Jun 21, 2004 · Terminated
  Tibial Base Plates
• Z-0304-05 · Jun 21, 2004 · Terminated
  Genesis Uni Articular Inserts