MAUDE Adverse Event Report: Stryker GmbH HUMERAL CUP - 36mm DIA X 4mm THK; prosthesis, shoulder, semi-constrained, metal/polymer cemented

Catalog Number	5570-3604
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A stryker reunion reverse shoulder implant was revised using new stryker reunion implants.
Additional Manufacturer Narrative
If additional information becomes available, it will be provided on a supplemental report.

• Brand Name: HUMERAL CUP - 36mm DIA X 4mm THK
• 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 ; +1(201)831-5000
• MDR Report Key: 50716217
• Report Number: 0008031020-2026-01577
• Device Sequence Number: 13278487
• Product Code: KWS
• UDI-Device Identifier: 07613327098365
• UDI-Public: 07613327098365
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 5570-3604
• Device Lot Number: 8M3E1W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 63 YR
• Patient Sex: Female