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REUNION 5573-6532Recalls & reported problems

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

All models of REUNION (113)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327098839), received between Feb 19, 2020 and Sep 8, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (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.

Reports received per month

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

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Fracture2
  • Break1
  • Loss of Osseointegration1

Patient problems

  • Failure of Implant2
  • Bone Fracture(s)1
  • Hematoma1
  • Injury1
  • Insufficient Information1
  • Loss of Range of Motion1
  • Osteopenia/ Osteoporosis1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjurySep 8, 2026Fracture

    It was reported that during a revision of a left ReUnion reverse shoulder arthroplasty, the tip of the center screw and one peripheral screw from the primary procedure were found to be broken. The existing components were revised and replaced with a new Stryker ReUnion baseplate, screws, cup, liner, and glenosphere.

    Patient problems: Insufficient Information

    MAUDE report 50673886 ↗
  • InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REUNION RSA STUDY: SUBJECT 02-051 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: 13.MAY.2021

    Patient problems: Bone Fracture(s); Loss of Range of Motion; Osteopenia/ Osteoporosis

    MAUDE report 17257266 ↗
  • InjuryJan 11, 2023Break; Fracture; Break; Fracture

    POST OP XRAY SHOWS BROKEN CENTER SCREW AND NOT BROKEN BUT PULLED THROUGH BASEPLATE.

    Patient problems: Failure of Implant

    MAUDE report 16141717 ↗
  • InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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 11368762 ↗
  • 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 9727816 ↗

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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