GENESIS 114861Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010050458), received between Apr 6, 2021 and Oct 11, 2021 — classified as 4 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2021Break; Break

  IT WAS REPORTED THAT A EXTRAMEDULLARY ALIGNMENT ROD WAS FOUND TO HAVE A BROKEN TIP. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT. NO ISSUES REPORTED FROM ANY CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12605827 ↗
• MalfunctionMay 6, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, A EXTRAMEDULLARY ALIGNMENT ROD WAS NOTICED TO BE BENT. NO CASE INVOLVED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784339 ↗
• MalfunctionApr 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE MALE END OF THE EXTRAMEDULLARY ALIGNMENT ROD CAME OUT. AS NOTICED DURING A FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741247 ↗
• MalfunctionApr 6, 2021Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS REPORTED THAT DURING A FIELD INSPECTION THE IPG MIS DCF AP CT BLK 3 WAS NOTED TO BE RUSTY AND DISCOLORED, THE EXTRAMEDULAR ALIGNMENT ROD WAS BROKEN, THE GII QUICK CONNECT HANDLE DENTED AND DID NOT RETRACT, THE IPG PS HIGH FLEX IMPCTR HD 1-2 GII PS HIGH FLEX IMPCTR HD 3-8, GII TIBIAL BASE IMPACTOR, GII NARROW PCL RETRACTOR, 11MM GNS II TIBIAL DRILL WITH BURRS AND GOUGES AND OUTER HOUSING CAP WITH ONE COMPONENT MISSING AND BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT PARTICIPATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617245 ↗