REUNION 5567-P-3014Recalls & reported problems
Stryker GmbH · Press-fit Humeral Stem · Class 2 · Implant
All models of REUNION (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327424812), received between Dec 1, 2020 and Nov 25, 2022 — classified as 3 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Bone Fracture(s)1
- Hemorrhage/Blood Loss/Bleeding1
- Implant Pain1
- Metal Related Pathology1
- Post Operative Wound Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "ACROMIAL STRESS FRACTURE NON-UNION. PATIENT EXPERIENCING PAIN OVER PROXIMAL AND DISTAL LOCKING BOLT SITES. REOPERATION TO REMOVE LOCKING BOLTS".
Patient problems: Bone Fracture(s); Implant Pain
MAUDE report 15864071 ↗InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A CASE DONE 6 WEEKS FOR THE REMOVAL OF A STRYKER SHOULDER STEM HAS METALLOSIS.
Patient problems: Metal Related Pathology
MAUDE report 15734095 ↗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. 11/2/2020: 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 10931086 ↗
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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