GAMMA 3325-0440SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613153313601), received between Aug 13, 2018 and Aug 13, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryAug 13, 2018Fracture

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿GAMMA 3 IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE GAMMA3 LOCKING NAIL SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 1-JAN-2005 AND 31-DEC-2016. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 290 COMPLAINTS WERE INITIATED FOR THE REVISION SURGERIES RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO SEQUELAE AFTER HIP FRACTURE. THE 60 OUT OF 290 CASES.

  Patient problems: No Code Available

  MAUDE report 7778923 ↗