MAUDE Adverse Event Report: ZIMMER BIOMET, INC. C/M 16 & 25MM PLUG WITH NOZZLE; EXTREMITIES IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 32810502604, interchangeable humeral assembly, lot # 65942779.Catalog #: 32810504301, interchangeable ulnar assembly plasma, lot # 65579058.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been requested but not returned by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : requested but not returned by hospital.
Event or Problem Description
It was reported that a patient had a primary surgery on approximately 2 months ago which was just washed out a month later was performed due to infection.The bearings were exchanged during washout.Attempts have been made and there is no further information at this time.
Event or Problem Description
After further review, it was determined to be not reportable as review of the sterile certs indicates the devices were sterilized per validated process / requirements.
Additional Manufacturer Narrative
(b)(4).After further review, it was determined to be not reportable as review of the sterile certs indicates the devices were sterilized per validated process / requirements.

• Brand Name: C/M 16 & 25MM PLUG WITH NOZZLE
• Common Device Name: EXTREMITIES IMPLANT
• 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: 17913682
• Report Number: 0001822565-2023-02837
• Device Sequence Number: 17993420
• Product Code: JDC
• UDI-Device Identifier: 00889024274082
• UDI-Public: (01)00889024274082(17)280515(10)66014334
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K040389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/27/2023

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: 32-8105-038-00
• Device Lot Number: 66014334
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female