REUNION 5572-4524Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327098730), received between Jul 30, 2018 and Jan 27, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION SURGERY INVOLVING REMOVAL OF THE REUNION GLENOID COMPONENTS AND IMPLANTATION OF A HUMERAL HEMIARTHROPLASTY HEAD.

  Patient problems: Bone Fracture(s); Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191006 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION OF LEFT SHOULDER. TRAY, LINER, BASEPLATE, GLENOSPHERE AND SCREWS WERE REMOVED, AND ANATOMIC HEAD WAS PLACED ON EXISTING STEM.

  Patient problems: Pain

  MAUDE report 22843528 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  TRAY, LINER, BASEPLATE, GLENOSPHERE AND SCREWS WERE REMOVED, AND ANATOMIC HEAD WAS PLACED ON EXISTING STEM. REVISION OF LEFT SHOULDER.

  Patient problems: Pain

  MAUDE report 22843271 ↗
• InjuryApr 12, 2024Break; Fracture; Break; Fracture

  THERE WAS A REVISION SURGERY DUE TO A FAILED GLENOID IN PREVIOUS YEARS, CAUSED BY A BROKEN CENTER SCREW AND PERIPHERAL SCREWS. THE STRYKER REUNION GLENOSPHERE AND BASEPLATE WITH BROKEN SCREWS WERE REMOVED, AND TORNIER GLENOID COMPONENTS WERE SUCCESSFULLY IMPLANTED. THE REVISION SURGERY WAS SUCCESSFUL WITHOUT ANY ADDITIONAL ADVERSE CONSEQUENCES, AND THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19098173 ↗
• InjuryApr 11, 2024Break; Fracture; Break; Fracture

  THERE WAS A REVISION SURGERY DUE TO A FAILED GLENOID IN PREVIOUS YEARS, CAUSED BY A BROKEN CENTER SCREW AND PERIPHERAL SCREWS. THE STRYKER REUNION GLENOSPHERE AND BASEPLATE WITH BROKEN SCREWS WERE REMOVED, AND TORNIER GLENOID COMPONENTS WERE SUCCESSFULLY IMPLANTED. THE REVISION SURGERY WAS SUCCESSFUL WITHOUT ANY ADDITIONAL ADVERSE CONSEQUENCES, AND THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19093676 ↗
• 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 18970005 ↗
• 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 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 18602377 ↗
• 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 HETEROTOPIC OSSIFICATION, ASYMPTOMATIC. INFERIOR SCAPULAR NECK OSTEOPHYTE, ASYMPTOMATIC"

  Patient problems: Extraskeletal ossification

  MAUDE report 18601589 ↗
• 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 18096711 ↗
• 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 17263123 ↗
• InjuryFeb 23, 2021Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  AS REPORTED: "THE PATIENT RETURNED TO DR.'S OFFICE FOR A FOLLOW-UP. UPON EXAMINING X-RAYS IT WAS OBVIOUS THAT PERIPHERAL SCREWS HAD MIGRATED THROUGH THE BASEPLATE REQUIRING REVISION SURGERY."

  Patient problems: Failure of Implant

  MAUDE report 11368863 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT EXPERIENCED EXCESS DRAINAGE FROM INCISION SITE ON (B)(6) 2020 THAT PERSISTED OVER 2 DAYS. PATIENT STARTED TAKING CEPHALEXIN 250 MG 4X/DAY ON (B)(6) 2020. PATIENT REPORTED IMPROVEMENT ON (B)(6) 2020. PATIENT WILL CONTINUE TO TAKE MEDICATION FOR TWO WEEKS AND WILL FOLLOW-UP FOR WOUND CHECK. (B)(6) 2020: INCISION BEGAN BLEEDING AGAIN ON (B)(6) 2020. PATIENT SEEN ON (B)(6) 2020, LABS ORDERED ON (B)(6) 2020. DUE TO EXCESS DRAINAGE, PLAN WILL BE REVISION SURGERY."

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Post Operative Wound Infection

  MAUDE report 10931102 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT RECEIVED A PRIMARY RSA ON (B)(6)2016 , WITH NO ISSUES. PATIENT CAME BACK AND HAD A SHOULDER SCOPE ON(B)(6)2019 , WHICH PRESENTED WHAT APPEARED TO BE VISIBLE METALLOSIS. PATIENT THEN CAME BACK ON (B)(6)2019 TO HAVE HIS RSA REMOVED AND HAVE A SHOULDER SPACER IMPLANTED." ADDITIONALLY REPORTED: "TISSUE WAS SENT TO THE LAB AND METALLOSIS, AS WELL AS P ACNES WERE CONFIRMED. PATIENT CURRENTLY AN ANTIBIOTIC SPACER IMPLANTED WITH GENT/VANC CEMENT AROUND THE HEAD/NECK JUNCTION."

  Patient problems: Injury; Reaction

  MAUDE report 9862621 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT RECEIVED A PRIMARY RSA ON (B)(6) 2016, WITH NO ISSUES. PATIENT CAME BACK AND HAD A SHOULDER SCOPE ON (B)(6) 2019, WHICH PRESENTED WHAT APPEARED TO BE VISIBLE METALLOSIS. PATIENT THEN CAME BACK ON (B)(6) 2019 TO HAVE HIS RSA REMOVED AND HAVE A SHOULDER SPACER IMPLANTED." ADDITIONALLY REPORTED: "TISSUE WAS SENT TO THE LAB AND METALLOSIS, AS WELL AS P ACNES WERE CONFIRMED. PATIENT CURRENTLY AN ANTIBIOTIC SPACER IMPLANTED WITH GENT/VANC CEMENT AROUND THE HEAD/NECK JUNCTION."

  Patient problems: Injury; Reaction

  MAUDE report 9862618 ↗
• InjuryFeb 19, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT SHOULDER WAS REVISED DUE TO IMPLANT LOOSENING. DUE TO THE PRESENCE OF A HEMATOMA, THE SURGEON REPORTED THAT TRAUMA HAD TO BE A FACTOR. THE PATIENT'S ENTIRE SHOULDER CONSTRUCT EXCEPT FOR THE HUMERAL STEM WAS REVISED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Injury

  MAUDE report 9727814 ↗
• InjuryFeb 19, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT SHOULDER WAS REVISED DUE TO IMPLANT LOOSENING. DUE TO THE PRESENCE OF A HEMATOMA, THE SURGEON REPORTED THAT TRAUMA HAD TO BE A FACTOR. THE PATIENT'S ENTIRE SHOULDER CONSTRUCT EXCEPT FOR THE HUMERAL STEM WAS REVISED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Injury

  MAUDE report 9727706 ↗
• InjuryOct 20, 2019Loose or Intermittent Connection

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9212571 ↗
• InjuryOct 20, 2019Loose or Intermittent Connection

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

  Patient problems: No Code Available

  MAUDE report 9212566 ↗
• 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 7732925 ↗
• 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: No Code Available

  MAUDE report 7732919 ↗