REUNION 5573-C-3206Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327098938), received between Oct 19, 2020 and Sep 18, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device Dislodged or Dislocated

  A revision surgery was performed as the device was dislocated and causing pain.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 50818653 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION SURGERY INVOLVING REMOVAL OF THE REUNION GLENOID COMPONENTS AND IMPLANTATION OF A HUMERAL HEMIARTHROPLASTY HEAD.

  Patient problems: Bone Fracture(s); Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191123 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-MARKET CLINICAL EVALUATION OF THE REUNION REVERSE SHOULDER ARTHROPLASTY (RSA) SYSTEM: (B)(4). DESCRIPTION OF THE EVENT: ACROMIAL STRESS REACTION. ACTIONS TAKEN: SLING FOR TWO WEEKS. RESOLVED WITH SEQUELAE: (B)(6) 2021.

  Patient problems: Bone Fracture(s)

  MAUDE report 17257071 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REUNION RSA STUDY: (B)(4). PATIENT FELT A POP 7 WEEKS POST-OP AND CAME IN. IMAGES SHOWED STRESS FRACTURE AT BASE OF ACROMION W/O SUBSTANTIAL DISPLACEMENT. SHE DOES HAVE OSTEOPOROSIS WHICH MAY HAVE CONTRIBUTED. ACTIONS TAKEN: SLING WITH LIMITED MOBILITY RESOLVED WITH SEQUELAE: (B)(6) 2021.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Osteopenia/ Osteoporosis

  MAUDE report 17255351 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT, CAME IN LAST WEEK ON 9/17 COMPLAINING OF PAIN AND REDNESS IN THE SHOULDER AS WELL AS A FEVER. AFTER DRAWING A SMALL AMOUNT OF CLOUDY FLUID, [SURGEON] SENT HER IMMEDIATELY TO THE ER AND HAD HER ADMITTED FOR A DEBRIDEMENT AND WASHOUT. SITE COORDINATOR HAS NOT SEEN THE RESULTS OF THE CULTURES YET, BUT SIGNS POINT TO INFECTION PER THE OPERATIVE REPORT AND CLINIC NOTE. [SURGEON] REMOVED AND EXCHANGED ALL HUMERAL COMPONENTS AS WELL AS THE GLENOSPHERE. HE LEFT THE ORIGINAL BASEPLATE. HE EXCHANGED THE OLD REUNION COMPONENTS WITH OTHER REUNION COMPONENTS."

  Patient problems: Erythema; Fever; Implant Pain; Unspecified Infection

  MAUDE report 10701777 ↗