REUNION 5573-C-3202Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327098877), received between Mar 21, 2019 and Nov 10, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  A REVISION SURGERY WAS PERFORMED DUE TO A PATIENT FALL THAT RESULTED IN THE IMPLANT BECOMING LOOSE AS WELL AS FALLING OUT OF ITS INTENDED POSITION.

  Patient problems: Fall

  MAUDE report 23511195 ↗
• 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 18970008 ↗
• 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). POST-OPERATIVE INFERIOR OSTEOPHYTE OFF OF GLENOID."

  Patient problems: Extraskeletal ossification

  MAUDE report 18597685 ↗
• 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 17969639 ↗
• 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 17159173 ↗
• InjuryNov 18, 2020Material Erosion; Device Damaged by Another Device; Material Erosion; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT REVERSE SHOULDER WAS REVISED AFTER PATIENT COMPLAINT OF PAIN AND X-RAYS SHOWING A PERIPHERAL SCREW LOOSE IN THE JOINT. INTRA-OPERATIVELY, IT WAS NOTED THAT THE PERIPHERAL SCREWS HAD 'WINDSHIELD WIPERED' IN THE JOINT, ETCHING THE GLENOSPHERE AND PASSING THROUGH THE BASEPLATE INTO THE JOINT. THE BASEPLATE, GLENOSPHERE AND CENTER SCREW CAME OUT ALL IN ONE PIECE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 10864580 ↗
• InjuryJul 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT REVERSE SHOULDER WAS REVISED DUE TO DISLOCATION OF THE POLY INSERT FROM THE GLENOID COMPONENT. REP REPORTED NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 10308714 ↗
• InjuryMar 17, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WE DID A SHOULDER REPLACEMENT AND AFTER SURGERY HE GOT POST OP XRAYS NOTICED THE GLENOSPHERE WASN¿T SEATED CORRECTLY. WENT BACK THE NEXT DAY AND REMOVED THE GLENOSPHERE AND REATTACHED IT CORRECTLY." ADDITIONALLY REPORTED: "PATIENT STAY WAS PROLONGED. STAYED OVERNIGHT HAD REVISION THE NEXT DAY AND RECOVERY DELAYED 24 HOURS."

  Patient problems: Injury

  MAUDE report 9845749 ↗
• InjuryOct 20, 2019Loose or Intermittent Connection

  SUSPECTED GLENOID LOOSENING OF REUNION RSA IMPLANTS LEADING TO REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 9212572 ↗
• 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 8688890 ↗
• 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 (B)(6). 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 8441692 ↗