REUNION 5573-6536Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327098846), received between Mar 21, 2019 and Jan 29, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 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: 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 18602357 ↗
• 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, ASYMPTOMATIC. INFERIOR SCAPULAR NECK OSTEOPHYTE, ASYMPTOMATIC".

  Patient problems: Extraskeletal ossification

  MAUDE report 18601633 ↗
• 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 17256966 ↗
• 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 15864177 ↗
• 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 13518623 ↗
• InjuryJun 7, 2019Device Dislodged or Dislocated

  THE PERIPHERAL SCREWS COMPLETELY DISASSOCIATED FROM THE GLENOID BASEPLATE, EVEN WITH THE GLENOSPHERE INTACT. THERE WAS SIGNIFICANT BONE LOSS ON THE GLENOID, AND THE MICROMOTION FROM THE BASEPLATE & SCREWS "ROCKING" LEFT UNCONTAINED DEFECTS IN THE GLENOID. THERE WAS METALLOSIS AROUND THE IMPLANTS AND OSTEOLYSIS AROUND THE HUMERAL CUP. REVISION SURGERY OCCURRED.

  Patient problems: Osteolysis; Toxicity

  MAUDE report 8680338 ↗
• InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  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: Unspecified Infection

  MAUDE report 8441684 ↗