MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE CENTRIC 40 MM DIAMETER +5 MM LATERAL OFFSET; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
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).G2, country event occurred in: japan.D10: item: 00436201500.Lot #: 66297134.Item name: base plate uncemented 15 mm post length.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.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
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.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d4, g1, g3, g6, h2, h4, h6, h10, h11.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.H6: component codes: proposed coded: mechanical (g04)- head.The reported event has been confirmed through the provided x-rays.D10 narrative: item: 00436201500, lot #: 66297134, item name: base plate uncemented 15 mm post length; 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: 110031429, lot # 65569219, item name: +3mm retentive thickness 40mm diameter bearing.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
No additional information is available regarding the incident.

• Brand Name: GLENOSPHERE CENTRIC 40 MM DIAMETER +5 MM LATERAL OFFSET
• 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: 20652239
• Report Number: 0001822565-2024-03530
• Device Sequence Number: 15123791
• Product Code: PHX
• UDI-Device Identifier: 00889024489578
• UDI-Public: (01)00889024489578(17)290831(10)64493954
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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 Model Number: N/A
• Device Catalogue Number: 00436504000
• Device Lot Number: 64493954
• 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
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Female