MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN 12MM HEIGHT SIZE E,F WITH LOCKING SCREW GREEN ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number	00599404012
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical product: stemmed tibial component precoat size 6: catalog#00598004702, lot#j7521674; right size f cemented option femoral component: catalog#00599401692, lot#65657682; distal femoral augment block size f 5 mm augment: catalog#00599003610, lot#63940929; distal femoral augment block size f 5 mm: catalog#00599003610, lot#65486528; 17mm diameter 100mm length straight stem extension: catalog#00598801017, lot#64222993; palacos r+g 1x40: catalog#ni, lot#ni, qty#2.G2: foreign: france the product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial right total knee arthroplasty, the articular surface was difficult to fit.While attempting to fit the bearing, the femoral components loosened and were then changed out for a smaller size.The original articular surface was fit successfully with the smaller femoral components.There was no patient impact and no adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to be 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 at time of this report.

• Brand Name: NEXGEN 12MM HEIGHT SIZE E,F WITH LOCKING SCREW GREEN ARTICULAR SURFACE
• 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: 19650726
• Report Number: 0001822565-2024-02200
• Device Sequence Number: 6550089
• Product Code: JWH
• UDI-Device Identifier: 00889024635814
• UDI-Public: (01)00889024635814(17)270401(10)65308425
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00599404012
• Device Lot Number: 65308425
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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.
• Patient Sex: Prefer Not To Disclose