REUNION 5570-3610Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327098372), received between Dec 1, 2018 and Jan 29, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 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.

• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "A POST-MARKET CLINICAL EVALUATION OF THE REUNION REVERSE. SHOULDER ARTHROPLASTY (RSA) SYSTEM: (B)(6). POSTOPERATIVE HETEROTOPIC OSSIFICATION, SYMPTOMATIC. HO OF SUPERIOR/POSTERIOR ASPECTS OF SHOULDER AND INFERIOR GLENOID NECK. SUBJECT COMPLAINS OF OCCASIONAL PAIN."

  Patient problems: Extraskeletal ossification; Implant Pain

  MAUDE report 18602084 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "A POST-MARKET CLINICAL EVALUATION OF THE REUNION REVERSE. SHOULDER ARTHROPLASTY (RSA) SYSTEM: SUBJECT 01-028R. INTRAOPERATIVE FRACTURE OF HUMERUS. NONDISPLACED GREATER TUBEROSITY FRACTURE."

  Patient problems: Bone Fracture(s)

  MAUDE report 18600057 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "INTRAOPERATIVE FRACTURE OF THE HUMERUS. EVENT WAS RESOLVED WITHOUT SEQUELAE (WITHOUT ADDITIONAL MEDICAL INTERVENTION)."

  Patient problems: Limb Fracture; Osteopenia/ Osteoporosis

  MAUDE report 18386966 ↗
• 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 13508716 ↗
• InjuryFeb 1, 2022Unstable; Unstable

  AS REPORTED: "SHOULDER INSTABILITY. THE SURGEON REPLACED THE SHOULDER STEM AND HUMERAL CUP AND INSERT." REVISION SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419043 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "INTRA-OP CULTURES CAME BACK POSITIVE FOR P. (B)(6) 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 10813647 ↗
• MalfunctionDec 1, 2018Contamination /Decontamination Problem

  THERE WERE WHITE FLAKES ON THE IMPLANT WHEN IT WAS REMOVED FROM THE PACKAGING. PHYSICIAN REMOVED THE WHITE FLAKES AND USED THE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8122214 ↗