Unknown NexGen Tibial Tray

Description of Event or Problem

It was reported that two (2) patients received anticoagulant therapy to treat post-operative deep vein thrombosis following knee arthroplasty.Attempts have been made and no further information has been provided.

Additional Manufacturer Narrative

(b)(4)Giabbani, N., Innocenti, M., Sangaletti, R., Matassi, F., Benazzo, F., Civinini, R., Mugnaini, M., Zanna, L. (2025) Coronal Alignment in Revision Total Knee Arthroplasty: A Comparison of Cemented Vs Press-Fit Stems for Restoring Mechanical Axis. Arthroplasty Today 35 (101863), 1-8.B3 - Date of PublicationD10: Concomitant Devices - Unknown NexGen Femoral Component Catalog #: NI Lot #: NI, Unknown NexGen Articular Surface Catalog #: NI Lot #: NI, Unknown NexGen Femoral Stem Catalog #: NI Lot #: NI, Unknown NexGen Tibial Stem Catalog #: NI Lot #: NIE1 - Correspondence Author.G2: Foreign - Event occurred in Italy.The reported event could not be confirmed as medical records were not provided. The device history records were not reviewed as the event was determined to be unrelated to the implanted device. Procedural-related complications are influenced by the type of surgery, patients' pre-existing comorbidities, and perioperative management. Deep vein thrombosis (DVT), or a blood clot, occurs when a blood clot forms in one of the deep veins of the body. This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops. Total joint patients are typically placed on medication post-operatively to prevent DVT formation. However, even with the administration of preventative medication, DVTs can still develop. As the reported event is for a procedural-related complication, the root cause was determined to be traced to non-device related factors.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.