REUNION 5901-IS-3204Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327100754), received between Dec 5, 2019 and Aug 3, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

• MalfunctionAug 3, 2020Fracture; Fracture

  IT WAS REPORTED, PRIMARY PROCEDURE, LEFT REVERSE TSA. IT WAS REPORTED THAT UPON TRYING TO REDUCE THE SHOULDER, THE CROWN OF THE HUMERAL INSERT TRIAL BROKE AWAY FROM THE REST OF THE TRIAL. PATIENT WAS VISUALLY INSPECTED TO ENSURE ALL PIECES WERE REMOVED. PROCEDURE COMPLETED WITH A CONSTRAINED TRIAL AND WAS COMPLETED SUCCESSFULLY WITH NO DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10359877 ↗
• MalfunctionDec 16, 2019Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED, A PRIMARY PROCEDURE, RIGHT SHOULDER. IT WAS REPORTED THAT AFTER IMPACTION, THE TRIAL IMPINGED AND GOT STUCK IN THE PATIENT. THE SURGEON USED A COCHER TO REMOVE THE TRIAL, AND TWO SMALL FRAGMENTS BROKE OFF OF THE TRIAL. ALL PIECES WERE REMOVED FROM THE PATIENT (VERIFIED BY VISUALLY INSPECTING THE PATIENT, PULSE LAVAGE, AND REASSEMBLY OF THE DEVICE AT THE BACK TABLE). SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5-10 MINUTES. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9477591 ↗
• MalfunctionDec 9, 2019Fracture; Fracture

  IT WAS REPORTED, A 32X4MM RSA HUMERAL CUP TRIAL BROKE WHEN THE SURGEON WAS DISLOCATING RSA TRIAL COMPONENTS AFTER TAKING THE PATIENT THROUGH A RANGE OF MOTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9441240 ↗
• MalfunctionDec 5, 2019Break; Break

  AS REPORTED: "DURING INSTRUMENT REBUILD FOUND BROKEN PIECES."

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9419628 ↗