MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE CD 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	Insufficient Information (4580)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently the patient underwent a revision approximately 3 years later due to unknown reasons.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2024 - 00267; 0001822565 - 2024 - 00269; 0001822565 - 2024 - 00270.Proposed component code: mechanical (g04)- head.G2: foreign: united kingdom.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b5, d1, d4, d10, g3, g4, g6, h2, h4, and h10.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2024-00085, 0001822565-2024-00268, 0002648920-2024-00087, and 0002648920-2024-00088.D10 medical devices: nexgen femoral component option size d right catalog#: 00596401452 lot#: 63500879.Nexgen stemmed nonaugmentable tibial component option cr/ps/lps size 3 catalog#: 00598603701 lot#: 64386879.Nexgen all poly patella standard cemented size 29 mm diameter catalog#: 00597206529.Lot#: 63848510.Palacos bone cement catalog#: 66017569 lot#: 94514870.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right knee revision approximately three years post-implantation for an unknown reason.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental 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.
Additional Manufacturer Narrative
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided as this was revision due to aseptic loosening of the tibia.
Event or Problem Description
Upon receipt of additional information, it was determined that the initial report was submitted in error and should be voided as this was revision due to aseptic loosening of the tibia.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE CD 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: 18586876
• Report Number: 0001822565-2024-00268
• Device Sequence Number: 6807297
• Product Code: JWH
• UDI-Device Identifier: 00889024211766
• UDI-Public: (01)00889024211766(17)260630(10)64064365
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/07/2025
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00596403010
• Device Lot Number: 64064365
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 03/01/2024; 08/29/2024; 03/14/2025
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/26/2024; 09/10/2024; 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2018
• 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
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown