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REUNION 5573-6524Recalls & reported problems

Stryker GmbH · 6.5mm CENTER SCREW · Class 2 · Implant

All models of REUNION (113)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327098815), received between Jul 10, 2018 and Jan 28, 2026 — classified as 8 injuries.

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

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated3
  • Adverse Event Without Identified Device or Use Problem2
  • Break1
  • Failure to Osseointegrate1
  • Fracture1
  • Loose or Intermittent Connection1

Patient problems

  • Fall2
  • No Code Available2
  • Bone Fracture(s)1
  • Extraskeletal ossification1
  • Failure of Implant1
  • Inadequate Osseointegration1
  • No Clinical Signs, Symptoms or Conditions1
  • Nonunion/Delayed-union Bone Fracture1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 28, 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 24198337 ↗
  • 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 19098169 ↗
  • 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 18597684 ↗
  • InjuryMar 22, 2023Failure to Osseointegrate; Failure to Osseointegrate

    A REVISION SURGERY WAS PLANNED DUE TO GLENOID FAILURE. IT IS SUSPECTED THAT THE REUNION BASEPLATE NEVER ACHIEVED BI CORTICAL FIXATION FROM THE CENTER SCREW.

    Patient problems: Inadequate Osseointegration

    MAUDE report 16594733 ↗
  • InjuryOct 20, 2019Loose or Intermittent Connection

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

    Patient problems: No Code Available

    MAUDE report 9212569 ↗
  • 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 8689019 ↗
  • InjuryOct 1, 2018Device Dislodged or Dislocated

    WE WERE REVISING A REVERSE TOTAL SHOULDER. THE BASEPLATE WITH THE GLENOSPHERE CAME OUT ALL TOGETHER. THERE WAS NO INGROWTH ON THE BASEPLATE. THE PATIENT HAD NO INFECTION. THE SURGEON HAD TO COVERT HIM TO A HEMI ARTHROPLASTY AS THERE WAS NO BONE LEFT AROUND THE GLENOID.

    Patient problems: No Code Available

    MAUDE report 7923892 ↗
  • InjuryJul 10, 2018Device Dislodged or Dislocated

    IN THIS REVISION OF A REUNION REVERSE SHOULDER, THE BASEPLATE HAD PULLED OUT OF GLENOID. ALL SCREWS PERIPHERAL SCREWS HAD LOOSENED WITH ONE ESCAPING THROUGH THE BACK OF THE BASE PLATE AND FLOATING FREE UNDER CLAVICLE. REP REPORTED THAT SURGEON WAS UNABLE TO RE-IMPLANT NEW BASEPLATE DUE TO BONE LOSS, AND THEREFORE PATIENT WAS CONVERTED TO A HEMI ARTHROPLASTY.

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 7675599 ↗

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

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