MAUDE Adverse Event Report: ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION TM PATELLA

Catalog Number 00587806541

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation in progress.

Event Description

Original descriptions patient in office to see dr.(b)(6).Don¿t know reason for coming in but i was sent by the surgeon the attached xray images of a fractured patella implant.Did not occur from fall according to patient.Avid cycling of around 30 miles per week.Event: fractured patella implant.Surgery details: as of now not planning on revising component.Nexgen tm standard primary patella is only the tmt design control part.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Review of the provided radiographs identified fracture of the patella implant.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.

Event Description

No further event information available at the time of this report.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION TM PATELLA
• Type of Device: PATELLA
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 8884884
• MDR Text Key: 154392556
• Report Number: 3005751028-2019-00018
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K011904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 00587806541
• Device Lot Number: 62622290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1