MAUDE Adverse Event Report: ZIMMER GMBH INVERS/REVERS SCR SYST 4.5-48; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	01.04223.048
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: item: 01.04223.048 - invers/revers scr syst 4.5-48 - lot: 3223284.Item: 00-4362-025-00 - 26 mmtm rvs base plt 25m - lot: 64858559.Item: 00-4360-040-00 - tm reverse glenosphere 4 - lot: 66719826.Item: 00-4349-040-03 - 40mm poly liner plus 3mm ofs - lot: 67312629.G2: foreign - event occurred in australia.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 revision due to unknown reasons.Attempts have been made and no further information has been provided.

• Brand Name: INVERS/REVERS SCR SYST 4.5-48
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25746503
• Report Number: 0009613350-2026-00348
• Device Sequence Number: 10129983
• Product Code: PHX
• UDI-Device Identifier: 00889024483064
• UDI-Public: (01)00889024483064(17)290408(10)3199119
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/08/2026

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?: No
• Device Catalogue Number: 01.04223.048
• Device Lot Number: 3199119
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male