MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM POLY LINER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	00434904006
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign - the event occurred in australia.Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: associated product information, part (lot): 436004000, (66418296).47436108300, (56672685).4743096125, (66640524).104223048, (3169732).104223042, (3198332).47430902501, (66762578).47430904601, (66952696).436202500, (64802668).434901413, (66297030).434903912, (65341696).434906603, (64442525).The customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.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 that a patient had an initial left reverse total shoulder arthroplasty.Subsequently, the patient was revised for an unknown reason.Attempts have been made, and no further information has been provided.

• Brand Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM POLY LINER
• 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 ; 5745260384
• MDR Report Key: 22967387
• Report Number: 0001822565-2025-03261
• Device Sequence Number: 9151074
• Product Code: PHX
• UDI-Device Identifier: 00889024633100
• UDI-Public: (01)00889024633100(17)260106(10)65582475
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 09/04/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00434904006
• Device Lot Number: 65582475
• 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: 08/06/2025
• Initial Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 01/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male