REUNION 5570-3204Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327098341), received between Mar 21, 2019 and Mar 25, 2024 — classified as 9 injuries.

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.

• 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 18969999 ↗
• 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: (B)(6). POSTOPERATIVE RADIOGRAPHIC LUCENCY, HUMERAL. MILD RADIOLUCENCY AROUND THE LATERAL TUBEROSITY JUST DISTAL TO THE GREATER TUBEROSITY ON THE DISTAL HUMERUS".

  Patient problems: Joint Laxity

  MAUDE report 18604966 ↗
• 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 (B)(6). POSTOPERATIVE RADIOGRAPHIC LUCENCY, HUMERAL. MILD LUCENCY SEEN IN ZONE 2 WITHOUT EVIDENCE OF HARDWARE LOOSENING".

  Patient problems: Joint Laxity

  MAUDE report 18597678 ↗
• InjuryOct 19, 2023Migration; Migration

  THIS IS A LEGAL CASE BEING REPORTED. THIS PRODUCT INQUIRY IS FOR THE REVISION SURGERY DUE TO IMPLANTS 'COMING APART/ SHIFTING' IN (B)(6) 2022. ANOTHER PRODUCT INQUIRY WAS OPENED FOR THE SCREW BREAKAGE. 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) OF 2022, A TOTAL SHOULDER REVISION WAS NEEDED BECAUSE THE SHOULDER 'CAME APART/ SHIFTED."

  Patient problems: Insufficient Information

  MAUDE report 17969714 ↗
• 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 17257489 ↗
• 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 17255391 ↗
• InjuryJun 19, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF RUBBING AND GRINDING IN THEIR ARM AND THE DOCTOR SAID IT WOULD GET BETTER. THE PATIENT SAYS THAT THEIR CONDITION HAS GOTTEN WORSE. THE PATIENT CANNOT USE THEIR ARM AND/OR RAISE IT ABOVE THEIR HEAD. PATIENT WANTS THEIR ARM FIXED AND IS SEEKING COMPENSATION. "EQUIPMENT" HAS COME APART IN PATIENT'S ARM. PATIENT MIGHT NEED A REVISION. CT SCAN IS SCHEDULED TO DETERMINE IF THERE IS ENOUGH BONE FOR A REVISION. PATIENT CANNOT WORK AND IS ON DISABILITY.

  Patient problems: Discomfort; Joint Dislocation; Loss of Range of Motion

  MAUDE report 17159313 ↗
• 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 8688896 ↗
• InjuryMar 21, 2019Appropriate Device Problem Term/Code Not Available

  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 8441673 ↗