REUNION 5572-4536Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327098761), received between Jul 30, 2018 and Aug 29, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Off-Label Use; Off-Label Use

  AS REPORTED: "EXPIRED DEVICE IMPLANTED IN THE PATIENT. WE WERE MADE AWARE OF EXPIRATION BEFORE PATIENT WAS OUT OF THE ROOM IT WAS AN EXPIRED PRODUCT FROM JANUARY".

  Patient problems: Insufficient Information

  MAUDE report 22922856 ↗
• InjuryJan 30, 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 01-004R POSTOPERATIVE HETEROTOPIC OSSIFICATION, SYMPTOMATIC. SUPERIOR GLENOID HO, PATIENT WAS STRUGGLING WITH OCCASIONAL SORENESS/TIGHTNESS SUBJECT SENT BACK TO PHYSICAL THERAPY TO IMPROVE RANGE OF MOTION AND STIFFNESS"

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 18606721 ↗
• InjuryJan 30, 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 01-004R POSTOPERATIVE HETEROTOPIC OSSIFICATION, SYMPTOMATIC. SUPERIOR GLENOID HO, PATIENT WAS STRUGGLING WITH OCCASIONAL SORENESS/TIGHTNESS SUBJECT SENT BACK TO PHYSICAL THERAPY TO IMPROVE RANGE OF MOTION AND STIFFNESS".

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 18606720 ↗
• 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: SUBJECT 02-067. 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 17258981 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY 6 WEEKS POST OP AND DEVELOPED METALLOSIS.

  Patient problems: Metal Related Pathology

  MAUDE report 15883222 ↗
• InjuryFeb 11, 2022Break; Fracture; Break; Fracture

  "IT WAS REPORTED THAT THE PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO A BROKEN PERIPHERAL AND CENTER SCREW IN THE BASEPLATE. ALL DEVICES EXCEPT FOR THE STEM WERE REVISED. THE CUP WAS REVISED IN ORDER TO ACCESS THE GLENOSPHERE AND BECAUSE THE SURGEON WANTED TO IMPLANT THICKER IMPLANTS."

  Patient problems: Failure of Implant

  MAUDE report 13518626 ↗
• InjuryJun 11, 2019Device Dislodged or Dislocated

  AS REPORTED: "PATIENT HAD IN REUNION REVERSE IMPLANTS. PATIENT FELL AND DISLOCATED. THE ATTENDING SURGEON THOUGHT GLENOSPHERE WAS NOT ALL THE WAY SEATED". REP CONFIRMED REVISION WAS PERFORMED BY INDICATING THAT THE HOSPITAL DISPOSED OF THE IMPLANTS.

  Patient problems: Fall

  MAUDE report 8689109 ↗
• InjuryMar 21, 2019Microbial Contamination of Device

  IT WAS REPORTED THAT A STAGE 1 REVISION OF THE PATIENT'S LEFT SHOULDER WAS PERFORMED DUE TO INFECTION. SURGEON REPORTED INFECTION AS MRSA. PATIENT'S ENTIRE SHOULDER CONSTRUCT WAS REMOVED AND A SPACER WAS PLACED. REP REPORTED THAT THE HOSPITAL AND SURGEON WILL NOT RELEASE ANY FURTHER INFORMATION.

  Patient problems: Bacterial Infection

  MAUDE report 8441674 ↗
• InjuryJul 30, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT SHOULDER WAS REVISED DUE TO THE GLENOSPHERE DISENGAGING FROM BASEPLATE. SURGEON SUSPECTED THE GLENOSPHERE MAY HAVE BEEN MALPOSITIONED AT TIME OF IMPLANT. ADDITIONALLY, PATIENT REPORTED HAD EXPERIENCED A FALL IN THE PAST YEAR.

  Patient problems: Fall

  MAUDE report 7732916 ↗