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
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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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