REUNION 5572-4516Recalls & reported problems
Stryker GmbH · 4.5mm PERIPHERAL SCREW · Class 2 · Implant
All models of REUNION (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Reunion shoulder prosthesis component is used in shoulder replacement surgery. The 39 reports describe parts coming loose or breaking — screws and baseplates separating from the bone — often leading to revision surgery, along with pain, bone fractures and extra bone growth. No deaths were reported; all 39 reports involved injuries. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07613327098716), received between Sep 5, 2018 and Jan 27, 2026 — classified as 39 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Problem27
- Device Dislodged or Dislocated6
- Break2
- Fracture2
- Device Slipped1
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of Osseointegration1
Patient problems
- Extraskeletal ossification9
- Bone Fracture(s)8
- Implant Pain8
- Loss of Range of Motion4
- Fall3
- Injury3
- Insufficient Information3
- No Code Available3
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 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 24191128 ↗InjuryJan 27, 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 24191015 ↗InjurySep 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION OF LEFT SHOULDER DUE TO PAIN AND A HALO BEHIND THE BASEPLATE.
Patient problems: Pain
MAUDE report 23155460 ↗InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT BASEPLATE AND PERIPHERAL SCREWS DISSOCIATED FROM THEIR NATIVE BONE. THE SURGEON DECIDED TO REMOVED THE ORIGINAL BASEPLATE AND SCREWS AND REINSTALL NEW HARDWARE FOR THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19253681 ↗InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT BASEPLATE AND PERIPHERAL SCREWS DISSOCIATED FROM THEIR NATIVE BONE. THE SURGEON DECIDED TO REMOVED THE ORIGINAL BASEPLATE AND SCREWS AND REINSTALL NEW HARDWARE FOR THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19253679 ↗InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT BASEPLATE AND PERIPHERAL SCREWS DISSOCIATED FROM THEIR NATIVE BONE. THE SURGEON DECIDED TO REMOVED THE ORIGINAL BASEPLATE AND SCREWS AND REINSTALL NEW HARDWARE FOR THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19253656 ↗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 19098773 ↗InjuryApr 11, 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 19093678 ↗InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT THEY ARE EXPERIENCING SORENESS AND PAIN. ADDITIONALLY, THE PATIENT WANTS TO KNOW IF THEIR IMPLANTS WERE PART OF ANY RECALL.
Patient problems: Discomfort; Implant Pain
MAUDE report 18970010 ↗InjuryJan 30, 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: (B)(6). POSTOPERATIVE HETEROTOPIC OSSIFICATION, SYMPTOMATIC. SUPERIOR GLENOID HO, PATIENT WAS STRUGGLING WITH OCCASIONAL SORENESS/TIGHTNESS SUBJECT SENT BACK TO PHYSICAL THERAPY TO IMPROVE RANGE OF MOTION AND STIFFNESS"
Patient problems: Extraskeletal ossification; Loss of Range of Motion
MAUDE report 18606727 ↗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)(4). POSTOPERATIVE HETEROTOPIC OSSIFICATION, SYMPTOMATIC. HO OF SUPERIOR/POSTERIOR ASPECTS OF SHOULDER AND INFERIOR GLENOID NECK. SUBJECT COMPLAINS OF OCCASIONAL PAIN."
Patient problems: Extraskeletal ossification; Implant Pain
MAUDE report 18602523 ↗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). POSTOPERATIVE HETEROTOPIC OSSIFICATION, SYMPTOMATIC. HO OF SUPERIOR/POSTERIOR ASPECTS OF SHOULDER AND INFERIOR GLENOID NECK. SUBJECT COMPLAINS OF OCCASIONAL PAIN."
Patient problems: Extraskeletal ossification; Implant Pain
MAUDE report 18602372 ↗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 01-029R. POSTOPERATIVE HETEROTOPIC OSSIFICATION, ASYMPTOMATIC. INFERIOR SCAPULAR NECK OSTEOPHYTE, ASYMPTOMATIC"
Patient problems: Extraskeletal ossification
MAUDE report 18600863 ↗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). POSTOPERATIVE HETEROTOPIC OSSIFICATION, ASYMPTOMATIC. INFERIOR SCAPULAR NECK OSTEOPHYTE, ASYMPTOMATIC".
Patient problems: Extraskeletal ossification
MAUDE report 18600849 ↗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: (B)(6). POST-OPERATIVE INFERIOR OSTEOPHYTE OFF OF GLENOID."
Patient problems: Extraskeletal ossification
MAUDE report 18597834 ↗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 01-024R POST-OPERATIVE INFERIOR OSTEOPHYTE OFF OF GLENOID."
Patient problems: Extraskeletal ossification
MAUDE report 18597690 ↗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 18597683 ↗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: (B)(6). POST-OPERATIVE INFERIOR OSTEOPHYTE OFF OF GLENOID."
Patient problems: Extraskeletal ossification
MAUDE report 18597682 ↗InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "I AM WRITING TO DRAW YOUR ATTENTION TO A DISTRESSING MEDICAL INCIDENT INVOLVING THE FAILED STRYKER REUNION RIGHT SHOULDER REPLACEMENT SURGERY ON (B)(6) 2020. THE PROCEDURE TOOK PLACE AT (B)(6). REGRETTABLY, DESPITE ENDURING NINE MONTHS OF PERSISTENT PAIN AND LIMITED RANGE OF MOTION, I UNDERWENT REVISION SURGERY ON (B)(6) 2021. PREOPERATIVE DIAGNOSIS: RIGHT SHOULDER FAILED REVERSE TOTAL SHOULDER ARTHROPLASTY, AXILLARY NERVE NEUROPRAXIA. POSTOPERATIVE DIAGNOSIS: CAT SCAN EVALUATION OF THE SHOULDER REVEALED AN OS ACROMIALE AND A FRACTURE LINE AROUND THE HUMERAL ENDOPROSTHESIS WITH PROXIMAL LOOSENING. INITIAL STAGES OF SCAPULAR NOTCHING WAS NOTED. THE METAPHYSEAL PORTION OF THE HUMERAL ENDOPROSTHESIS WAS INFERIOR AND SLIGHTLY MEDIAL TO THE INFERIOR ASPECT OF THE GLENOID. THE CENTER OF ROTATION OF THE REVERSE TOTAL SHOULDER ARTHROPLASTY APPEARED NONLATERALIZED."
Patient problems: Implant Pain; Loss of Range of Motion; Nerve Damage
MAUDE report 17460593 ↗InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REUNION RSA STUDY: SUBJECT (B)(6). 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: (B)(6) 2021.
Patient problems: Bone Fracture(s); Loss of Range of Motion; Osteopenia/ Osteoporosis
MAUDE report 17258201 ↗InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POST-MARKET CLINICAL EVALUATION OF THE REUNION REVERSE SHOULDER ARTHROPLASTY (RSA) SYSTEM: (B)(4). DESCRIPTION OF THE EVENT: ACROMIAL STRESS REACTION ACTIONS TAKEN: SLING FOR TWO WEEKS RESOLVED WITH SEQUELAE: (B)(6) 2021.
Patient problems: Bone Fracture(s)
MAUDE report 17256006 ↗InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POST-MARKET CLINICAL EVALUATION OF THE REUNION REVERSE SHOULDER ARTHROPLASTY (RSA) SYSTEM: SUBJECT (B)(6). DESCRIPTION OF THE EVENT: ACROMIAL STRESS REACTION. ACTIONS TAKEN: SLING FOR TWO WEEKS. RESOLVED WITH SEQUELAE: (B)(6) 2021.
Patient problems: Bone Fracture(s)
MAUDE report 17255700 ↗InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REUNION RSA STUDY: (B)(4). 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: (B)(6) 2021.
Patient problems: Bone Fracture(s); Loss of Range of Motion; Osteopenia/ Osteoporosis
MAUDE report 17253939 ↗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 15864203 ↗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 15864202 ↗
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.
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