MAUDE Adverse Event Report: Zimmer Biomet, Inc. Comprehensive Reverse Shoulder Augmented Baseplate; Shoulder Prosthesis, Reverse Configuration

Catalog Number	110032420
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
Event or Problem Description
It was reported the patient had a reverse shoulder system implanted.Approximately, 4 months post-operation, the patient reported increasing pain over the last 6 weeks to the surgeon.X-rays confirmed the broken screws and baseplate and taper adapted disassociation.Future revision surgery plan and date unknown.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in australia.Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.The customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.- d10: concomitant medical products, part (lot): -115396(67466445) -180552(67436045) -180553(67627484) -180552(67366327) -180552(67538969) if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: Comprehensive Reverse Shoulder Augmented Baseplate
• 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: 50868970
• Report Number: 0001825034-2026-02835
• Device Sequence Number: 16138099
• Product Code: PHX
• UDI-Device Identifier: 00880304993242
• 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: 110032420
• Device Lot Number: 67299945
• 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: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See h11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male