REUNION 5572-4520Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327098723), received between Jul 5, 2023 and Sep 8, 2026 — classified as 10 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Fracture

  It was reported that during a revision of a left ReUnion reverse shoulder arthroplasty, the tip of the center screw and one peripheral screw from the primary procedure were found to be broken. The existing components were revised and replaced with a new Stryker ReUnion baseplate, screws, cup, liner, and glenosphere.

  Patient problems: Insufficient Information

  MAUDE report 50672935 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a revision of a left ReUnion reverse shoulder arthroplasty, the tip of the center screw and one peripheral screw from the primary procedure were found to be broken. The existing components were revised and replaced with a new Stryker ReUnion baseplate, screws, cup, liner, and glenosphere.

  Patient problems: Insufficient Information

  MAUDE report 50672933 ↗
• InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT BASEPLATE AND PERIPHERAL SCREWS DISSOCIATED FROM THEIR NATIVE BONE. THE SURGEON DECIDED TO REMOVED THE ORIGINAL BASEPLATE AND SCREWS AND REINSTALL NEW HARDWARE FOR THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19253645 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY ARE EXPERIENCING SORENESS AND PAIN. ADDITIONALLY, THE PATIENT WANTS TO KNOW IF THEIR IMPLANTS WERE PART OF ANY RECALL.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 18970004 ↗
• 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 01-007L 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 18602362 ↗
• InjuryJan 3, 2024Break; Fracture; Osseointegration Problem; Break; Fracture; Osseointegration Problem

  AS REPORTED; "SURGEON SCHEDULED A REVISION SURGERY WITH THE STRYKER REPRESENTATIVE. DURING THE SURGERY, IT WAS DETERMINED THAT THE BASEPLATE/SCREW/GLENOSPHERE CONSTRUCT WAS LOOSE. ONE SCREW WAS BROKEN. THE GLENOID BASEPLATE/GLENOSPHERE/SCREWS WERE EXPLANTED. THE CUP/POLY CONSTRUCT WAS EXPLANTED FROM THE HUMERAL SIDE. A 36MM STRYKER CUP/POLY CONSTRUCT WAS REPLACED ON THE HUMERAL STEM."

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 18436509 ↗
• InjuryNov 8, 2023Osseointegration Problem; Osseointegration Problem

  THE SURGEON SCHEDULED A REVISION SURGERY WITH A STRYKER REPRESENTATIVE. DURING THE SURGERY, IT WAS FOUND THAT THE BASEPLATE/SCREW/GLENOSPHERE CONSTRUCT WAS LOOSE, WITH TWO OF THE FOUR SCREWS NOT CONTAINED WITHIN THE CONSTRUCT. THE GLENOID BASEPLATE/GLENOSPHERE/SCREWS AND THE CUP/POLY CONSTRUCT WERE REMOVED. A 40MM HUMERAL HEAD WAS ATTACHED TO THE EXISTING HUMERAL STEM. THE INDICATION FOR THE PRIMARY PROCEDURE WAS A FRACTURE. THE REVISION SURGERY WAS SUCCESSFUL.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 18096791 ↗
• InjuryNov 8, 2023Osseointegration Problem; Osseointegration Problem

  DURING A SCHEDULED REVISION SURGERY WITH THE STRYKER REPRESENTATIVE, IT WAS DISCOVERED THAT THE BASEPLATE/SCREW/GLENOSPHERE CONSTRUCT WAS LOOSE, WITH TWO OF THE FOUR SCREWS NOT CONTAINED WITHIN THE CONSTRUCT. CONSEQUENTLY, THE GLENOID BASEPLATE/GLENOSPHERE/SCREWS WERE REMOVED, AND THE CUP/POLY CONSTRUCT WAS EXPLANTED FROM THE HUMERAL SIDE. A 40MM HUMERAL HEAD WAS ATTACHED TO THE EXISTING HUMERAL STEM. THE PRIMARY SURGERY INVOLVED A FRACTURE. THE REVISION SURGERY WAS SUCCESSFUL.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 18096789 ↗
• InjuryOct 19, 2023Break; Fracture; Break; Fracture

  THIS IS A LEGAL CASE. THIS PRODUCT INQUIRY IS FOR THE REVISION SURGERY DUE TO SCREW BREAKAGE IN (B)(6) 2022. ANOTHER PRODUCT INQUIRY WAS OPENED FOR THE IMPLANTS 'COMING APART/ SHIFTING'. AS REPORTED: "PATIENT CALLED STATING HE HAD A SHOULDER REPLACEMENT IN (B)(6) 2021. IN (B)(6)2022, A REVISION WAS NEEDED DUE TO A BROKEN SCREW. IN (B)(6) 2022, A TOTAL SHOULDER REVISION WAS NEEDED BECAUSE THE SHOULDER 'CAME APART/ SHIFTED."

  Patient problems: Failure of Implant

  MAUDE report 17969635 ↗
• 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 17254137 ↗