MAUDE Adverse Event Report: Zimmer Biomet, Inc. 25MM VERSA-DIAL TAPER ADAPTOR; Shoulder Prosthesis, Reverse Configuration

Catalog Number	118000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a reverse shoulder procedure, the patient later required two surgeries due to disengagement of the glenosphere from the reverse baseplate and disassociated.The reporter attributed these occurrences in part to patient non-compliance and to the central screw not being seated sufficiently to allow proper seating of the glenosphere.The patient underwent two revision surgeries and this reported event is covering the second revision surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10: associated products also revised item #: 115313.Comp rvsr shldr glnsp +3 36mm lot #: unk.Item #: 110031418 cr prolong 36mm brng std.Lot #: unk item #: 110031399.Hmrl tray std std lot #: unk.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: 25MM VERSA-DIAL TAPER ADAPTOR
• Common Device Name: Shoulder Prosthesis, Reverse Configuration
• Manufacturer (Section D): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50038001
• Report Number: 0001822565-2026-02685
• Device Sequence Number: 13367286
• Product Code: PHX
• UDI-Device Identifier: 00880304531048
• UDI-Public: 00880304531048
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K202232
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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
• Device Catalogue Number: 118000
• Device Lot Number: Unk
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: See H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 LB