MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 36MM DIA X 6MM THK 2MM ECCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5573-2E-3606
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
A revision surgery was performed due to disassociation of the glenosphere.
Event or Problem Description
A revision surgery was performed due to disassociation of the glenosphere.
Additional Manufacturer Narrative
The reported event could not be confirmed, as although the device was returned for evaluation, the required medical documentation was not provided to support the assessment.The received devices were visually inspected, and no major damage was observed.The returned glenosphere exhibited markings around the superior surface, which may be attributable to exposure to body fluids or residual moisture.Additionally, scratch marks were noted on the inferior surface of the glenosphere, indicating device placement and contact with an adjacent component during use.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Glenosphere are hundred percent dimensionally inspected which eliminates any manufacturing concerns related device.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation based on the investigation, the root cause could not be determined due to the absence of required medical documentation no major observations observed on returned product.If any additional information is provided, the investigation will be reassessed.

• Brand Name: GLENOSPHERE - 36MM DIA X 6MM THK 2MM ECCENTRIC
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24507240
• Report Number: 0008031020-2026-00361
• Device Sequence Number: 13229132
• Product Code: KWS
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5573-2E-3606
• Device Lot Number: P686R3
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 237 LB
• Patient Race: White