REUNION 5573-2E-3606Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327098907), received between Oct 4, 2018 and Mar 4, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Device Dislodged or Dislocated

  A REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION OF THE GLENOSPHERE.

  Patient problems: Joint Dislocation

  MAUDE report 24507240 ↗
• InjuryApr 10, 2024Unstable; Unstable

  THE PATIENT UNDERWENT A REVISION SURGERY. IN AN UPDATE, IT WAS MENTIONED THAT THE PATIENT WAS UNSTABLE, LEADING THE SURGEON TO CHANGE THE IMPLANTS TO ADDRESS THE INSTABILITY ISSUES. REUNION IMPLANTS WERE USED TO UPSIZE THE IMPLANTS AND WASH OUT THE PATIENT DURING THE SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 19079459 ↗
• InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ACROMIAL STRESS FRACTURE NON-UNION. PATIENT EXPERIENCING PAIN OVER PROXIMAL AND DISTAL LOCKING BOLT SITES. REOPERATION TO REMOVE LOCKING BOLTS".

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 15864161 ↗
• InjuryFeb 21, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE WRONG SIZE/INCORRECT IMPLANT WAS OPENED AND IMPLANTED INTO A PATIENT. PATIENT HAD TO HAVE THE INCORRECT IMPLANT REMOVED AND THE CORRECT ONE IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569884 ↗
• InjuryFeb 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "THE SURGEON REVISED PATIENT TO NEW STEM, GLENOSPHERE, CUP AND LINER DUE TO REOCCURRING DISLOCATIONS." NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13508770 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "AS REPORTED: "INTRA-OP CULTURES CAME BACK POSITIVE FOR P. ACNES. NO GROSS PURULENCE NOTED DURING SURGERY. PATIENT STARTED TAKING AMOXICILLIN ON (B)(6) 2020. CONTINUED FOLLOW-UP SCHEDULED WITH INFECTIOUS DISEASE CLINIC TO MONITOR."

  Patient problems: Bacterial Infection

  MAUDE report 10813521 ↗
• InjuryOct 4, 2018Material Fragmentation; Device Dislodged or Dislocated; Naturally Worn

  PATIENT SAYS THAT PEOPLE IN THE NURSING HOME MIGHT HAVE CAUSED HIS PROBLEM BY PULLING HIM UP UNDER HIS ARM.. THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE, CAUSING HIM PAIN AND DISCOMFORT. THIS HAD BEEN OUT OF PLACE FOR AWHILE. HE HAD A FAIR AMOUNT OF METALLOSIS IN THE JOINT. BECAUSE OF WEAR ON THE BASEPLATE, EVERYTHING HAD TO BE CHANGED TO NEW COMPONENTS EXCEPT FOR THE STEM WHICH WAS FOUND TO BE INTACT AND NOT LOOSE. THIS WAS THE PATIENT'S RIGHT SHOULDER.

  Patient problems: Discomfort; Pain

  MAUDE report 7933764 ↗