MAUDE Adverse Event Report: Zimmer Biomet, Inc. COMP RVS CNTRL 6.5X30MM ST/RST; Shoulder prosthesis, reverse configuration

Catalog Number	115396
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury

• Brand Name: COMP RVS CNTRL 6.5X30MM ST/RST
• Common Device Name: Shoulder prosthesis, reverse configuration
• Manufacturer (Section D): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): Zimmer Biomet, Inc.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50904230
• Report Number: 0001825034-2026-02875
• Device Sequence Number: 12238147
• Product Code: PHX
• UDI-Device Identifier: 00880304677081
• UDI-Public: (01)00880304677081(17)350903(10)67466445
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 115396
• Device Lot Number: 67466445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 09/03/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male