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	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device will be returned for analysis; 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 on an unknown date that the device design did not fit intra-operatively and the surgeon converted to an augmented base plate.The surgeon abandoned the planned device and used an augmented base plate to complete the procedure.No environmental or handling factors were reported.The patient experienced no known impact or consequence.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: a1; a2; a3;b7; h2; h3; h6.The reported event could not be confirmed as product was not returned.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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: 23656885
• Report Number: 0001825034-2025-03796
• Device Sequence Number: 4770501
• Product Code: PHX
• UDI-Device Identifier: 00880304818934
• UDI-Public: (01)00880304818934(17)260401(10)67603095
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K202232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Catalogue Number: 110027734
• Device Lot Number: 67603095
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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
• Patient Sex: Male