MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 7; PROSTHESIS, KNEE

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	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was revised approximately 11 days post implantation due to infection.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: 00596401752 - nexgen femoral component - 64226461; 00596405010 - nexgen articular surface - 65054651.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report should be voided.Upon receiving additional information, this product is not involved in this event.It was previously reported under 0001822565-2024-03573.
Event or Problem Description
This report should be voided.Upon receiving additional information, this product is not involved in this event.It was previously reported under 0001822565-2024-03573.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 7
• Common Device Name: PROSTHESIS, KNEE
• 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: 20746614
• Report Number: 0002648920-2024-00358
• Device Sequence Number: 18233217
• Product Code: JWH
• UDI-Device Identifier: 00889024218871
• UDI-Public: (01)00889024218871(17)280430(10)64030673
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• 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: Consumer,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: 00598605701
• Device Lot Number: 64030673
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2018
• 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 Sex: Male