GLOBAL UNITE 2100-06-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295085232), received between Aug 13, 2019 and Aug 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionAug 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THIS WAS A PROSTHESIS INSERTION PROCEDURE PERFORMED ON (B)(6) 2019. THE SURGEON WAS NOT ABLE TO CONNECT THE HUMERAL STEM 6 MM (210006100) TO THE PROXIMAL BODY 10 TRIALS (210030000, 210030010, 210030020) WITH SCREWS. WHEN THE SURGEON REPLACED WITH OTHER PROXIMAL BODY 10 TRIAL(S), S/HE WAS ABLE TO SCREW IN TO A CERTAIN POINT, BUT THE SCREWS DID NOT GO ANY FURTHER. THE PROCEDURE WAS DELAYED FOR LESS THAN 30 MINUTES. THE DEVICES WERE BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Not Applicable

  MAUDE report 8889647 ↗