MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR VRS GLEN PPS MIN TPR ADR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110027734
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in japan.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.
Event or Problem Description
It was reported that the patient underwent a shoulder procedure with implantation of a glenoid component.Approximately two years post-implantation, the patient presented with pain, and radiographs showed that all screws securing the glenoid component had fractured.Subsequently, an extraction surgery was performed approximately 25 months post-implantation.Intra-operatively, the glenoid component was not integrated with bone and was floating, allowing for easy manual removal.All fractured screws were extracted using a removal kit.The stem remained stable, and the stem, tray, and liner were retained.The patient had a history of reoperation due to infection and metal allergies.The patient was revised.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Please void this report already submitted under (b)(4).Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034-2025-02987.
Event or Problem Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0001825034-2025-02987.

• Brand Name: COMPR VRS GLEN PPS MIN TPR ADR
• 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 ; 5745260384
• MDR Report Key: 24190631
• Report Number: 0001825034-2026-00220
• Device Sequence Number: 9575269
• Product Code: PHX
• UDI-Device Identifier: 00880304818934
• UDI-Public: (01)00880304818934(17)240406(10)66344568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Expiration Date: 04/06/2024
• Device Catalogue Number: 110027734
• Device Lot Number: 66344568
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown