MAUDE Adverse Event Report: Zimmer Biomet, Inc. Comprehensive Reverse Shoulder Mini Humeral Tray; Shoulder Prosthesis, Reverse Configuration

Catalog Number	110031399
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4)\ g2: foreign - the event occurred in australia\ \ d10: concomitant medical products, part (lot): \ - unknown humeral stem(unknown)\ \ the customer has indicated that the product will not be returned to zimmer biomet for investigation due to the hospital not returning the device.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.\ \ if any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported the patient underwent a reverse shoulder procedure.Subsequently, the patient had a revision procedure due to mini humeral tray dissociation from stem approximately 1 week post-implantation.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.\ \ the following sections were updated/corrected:\ b4; b5; d2; e1; g1; g3; g6; h1; h2.

• Brand Name: Comprehensive Reverse Shoulder Mini Humeral Tray
• 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: 50764163
• Report Number: 0001822565-2026-03117
• Device Sequence Number: 13110462
• Product Code: PHX
• UDI-Device Identifier: 00887868231315
• UDI-Public: (01)00887868231315(17)360128(10)67697092
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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): 09/14/2026

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: 110031399
• Device Lot Number: 67697092
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown