MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI STANDARD THICKNESS +0MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: australia.D10 narrative: item #: 110032410.Lot #:66704131.Item name: comp aug mini bsplt w tpr sm.Item: # 110031424.Lot #: 66747265.Item name: standard 36mm diameter bearing.Item #: number115310.Lot #: j7574137.Item name: comp rvrs shldr glnsp std 36mm.The product will not be evaluated by zimmer biomet as the product was requested but not returned by the hospital.Once the investigation has been completed, a follow up/final report will be submitted.
Event or Problem Description
It was reported that the patient underwent shoulder surgery.Subsequently, the patient was revision due to infection.The infection was treated with wash out and replacement of humeral tray, bearing, and the glenosphere.There was harm or injury to patient as the patient had to undergo additional surgical/medical procedure.Due diligence is complete.No additional information is available.
Event or Problem Description
No additional information is available regarding the incident.
Additional Manufacturer Narrative
This event is recorded by zimmer biomet under cmp-(b)(4).Void.Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.

• Brand Name: MINI STANDARD THICKNESS +0MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY
• 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: 20784864
• Report Number: 0001822565-2024-03723
• Device Sequence Number: 5004539
• Product Code: PHX
• UDI-Device Identifier: 00887868231315
• UDI-Public: (01)00887868231315(17)340618(10)66714727
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110031399
• Device Lot Number: 66714727
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female