MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 40MM GLENOSPHERE CEN +3LAT OFS; REVERSE SHOULDER PROSTHESIS HEAD

Catalog Number	00436304000
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a revision procedure approximately 3 months post implantation after complaining of discomfort.Prior to the revision, an x ray revealed what appeared to be a fractured taper that had disengaged from the glenosphere.A new glenosphere, bearing, and baseplate were implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: mini base plate 20mm post cat# 00436202000 lot# 66526038.H6: mechanical (g04) - head.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information is 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: b4, b5, g3, g6, h2, h3, h6, h11 visual examination of the returned product identified the glenosphere shows sign of use with some scuffs and scratches on the od of the glenosphere.There is also some wear and tear on the id of the glenosphere.Measured the glenosphere and it is conforming to the print.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the left shoulder demonstrates a reverse total shoulder arthroplasty.On the second image, there appears to be disassociation of the glenosphere from the glenoid base.No dislocation.No definite fracture.A definitive root cause cannot be determined.The reported event is confirmed for disassociation as x-rays were provided.No fracture was detected.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: 40MM GLENOSPHERE CEN +3LAT OFS
• Common Device Name: REVERSE SHOULDER PROSTHESIS HEAD
• 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: 22001708
• Report Number: 0001822565-2025-01334
• Device Sequence Number: 17947135
• Product Code: PHX
• UDI-Device Identifier: 00889024489554
• UDI-Public: (01)00889024489554(17)340309(10)66390309
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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?: Yes
• Device Catalogue Number: 00436304000
• Device Lot Number: 66390309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male