MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE EF 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a left knee revision approximately forty-six months post-implantation due to limited flexion.No additional patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).D10 medical devices: nexgen left size e cemented option femoral component catalog#: 00599401591 lot#: 64579776 10mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801010 lot#: 64742770 allen medullary cement plugs 1-24 mm diameter flange catalog#: 00801102024 lot#: 64563093 allen medullary cement plugs 1-20 mm diameter flange catalog#: 00801102020 lot#: 64573394 11mm diameter 100mm length offset stem extension combined length 145mm catalog#: 00598802011 lot#: 64678175 size 5 precoat cemented stemmed anterior/posterior wedged tibial component catalog#: 00598800500 lot#: 64475646 all poly patella standard cemented size 35 mm diameter 9.0 mm thickness catalog#: 00597206535 lot#: 64740060 anterior femoral augment block precoat size e catalog#: 00599003531 lot#: 63381604.G2 foreign source: australia customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the explanted implants with foreign material on their surface.As the devices were not returned, further evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.A definitive root cause cannot be determined.The complaint is not confirmed.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 further event information available at the time of this report.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE EF 10 MM HEIGHT
• 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: 20878679
• Report Number: 0001822565-2024-03869
• Device Sequence Number: 18105565
• Product Code: JWH
• UDI-Device Identifier: 00889024211247
• UDI-Public: (01)00889024211247(17)220630(10)63697584
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00596204010
• Device Lot Number: 63697564
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2017
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male