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
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
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page