MAUDE Adverse Event Report: ZIMMER BIOMET, INC. +3MM RETENTIVE THICKNESS 40MM DIAMETER BEARING; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031429
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event has been confirmed through the provided x-rays.D10 narrative: item: 00436504000, lot #: 64493954, item name: glenosphere centric 40 mm diameter +5mm lateral offset.Item: 0104223018, lot # 3187113, item name: anatomical shoulderâ¿¢ reverse, screw system, 4.5-18.Item: 0104223018, lot # 3198214, item name: anatomical shoulderâ¿¢ reverse, screw system, 4.5-18.Item: 11003142900.Lot # unknown.Item name: vivacit-e bearing 40mm +3 ret/ item: 00436201500, lot # 66297134, item name: base plate uncemented 15 mm post length.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient was revised due to dislocation.There was harm or injury to patient as the patient has to underwent additional surgical/medical procedure.Due diligence is complete.No additional information is available.

• Brand Name: +3MM RETENTIVE THICKNESS 40MM DIAMETER BEARING
• 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: 21465538
• Report Number: 0001822565-2025-00474
• Device Sequence Number: 16996749
• Product Code: PHX
• UDI-Device Identifier: 00887868231605
• UDI-Public: (01)00887868231605(17)270915(10)65569219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/25/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 110031429
• Device Lot Number: 65569219
• 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: 10/18/2024
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female