MAUDE Adverse Event Report: Zimmer Biomet, Inc. COMP RVSR SHLDR GLNSP +3 36MM; Shoulder Prosthesis, Reverse Configuration

Catalog Number	115313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a right total reverse shoulder arthroplasty and subsequently required a revision approximately 4 weeks post-implantation due to instability.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) h6: proposed annex g code: mechanical (g04) - head the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: COMP RVSR SHLDR GLNSP +3 36MM
• 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: 50114822
• Report Number: 0001825034-2026-02255
• Device Sequence Number: 5305579
• Product Code: PHX
• UDI-Device Identifier: 00880304475779
• UDI-Public: (01)00880304475779(17)350516(10)J7954378
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 115313
• Device Lot Number: J7954378
• 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: 07/08/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Male