Innomed, Inc. 5202-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840277104496), received between Aug 10, 2017 and Aug 10, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 18, 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 10, 2017Break

  THE FOLLOWING DESCRIPTION WAS RECEIVED BY THE CDRH ON 6/30/2017 WITH ASSIGNED MDR REPORT KEY (B)(4): A 50MM RADIOTRANSPARENT TRIAL FEMORAL HEAD BROKE UPON INSERTION IN THE LEFT HIP. RESPONSE: THE REPORT WAS RECEIVED BY THE IMPORTER ON (B)(6) 17. THE INITIAL REPORTER WAS CONTACTED VIA PHONE ON THE SAME DATE, AND A REQUEST WAS MADE TO FORWARD PICTURES OF THE DEVICE BECAUSE BASED ON THE DESCRIPTION IN THE REPORT, IT WAS NOT UNDERSTOOD HOW THE DEVICE WAS DETERMINED TO BE AN INNOMED PART. PICTURES OF THE DEVICE WAS RECEIVED AT INNOMED ON (B)(6) 2017, AND AFTER REVIEW, IT WAS VERIFIED AS AN INNOMED PART. THE IMPORTER ALSO REQUESTED MORE INFORMATION VIA EMAIL REGARDING THE SERIES OF EVENTS THAT LED TO THE BREAK AS THE ABOVE DESCRIPTION IS NOT SUFFICIENT ENOUGH TO PERFORM A THOROUGH INVESTIGATION. A FOLLOW UP EMAIL WAS SENT ON (B)(6) 2017 REQUESTING THE SAME INFORMATION. NO RESPONSE WAS RECEIVED FROM THE INITIAL REPORTER. WHEN THE REQUESTED INFORMATION IS PROVIDED, AN INVESTIGATION WILL ENSUE, AND AN UPDATE WILL BE FORWARDED TO THE CDRH.

  Patient problems: Failure of Implant

  MAUDE report 6785866 ↗