MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	115399
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the reported event is not confirmed.Visual evaluation of the returned packaging found the inner pouch was not sealed but folded over, however, this is the specified packaging method as required by manufacturing specifications.The outer pouch had been previously opened as intended using the vendor seal.Evaluation of the seal found no non-conformance.The customer reported the carton was fully sealed, however, as no photos were provided or carton returned, evaluation of the carton could not be performed to determine when or how the carton may have been opened.Based on the information provided, the packaging was likely opened and resealed after release from zimmer biomet, however, this cannot be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided for review.A definitive root cause cannot be determined.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 that the peel pack of the sterile device was completely unsealed inside of a sealed and wrapped box.The implant was returned in the peel packaging exactly as it was removed from outer box.The procedure was completed successfully with an anternate device.It was reported that no further information is available.

• Brand Name: COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW
• 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: 23945770
• Report Number: 0001825034-2026-00009
• Device Sequence Number: 10683223
• Product Code: PHX
• UDI-Device Identifier: 00880304677111
• UDI-Public: (01)00880304677111(17)300611(10)872450
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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 Catalogue Number: 115399
• Device Lot Number: 872450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• 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: 12/03/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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 Age: 66 YR
• Patient Sex: Male