MAUDE Adverse Event Report: ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION TRABECULAR METAL PRIMARY PATELLA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 06/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported event was able to be confirmed by visual inspection of the patella, which exhibited signs of being implanted and the post fractured off.A review of the device history records was unable to be performed as lot number was not provided.Medical records and radiographs were provided and reviewed by a hcp.Review of the available records identified a dislodged patellar hardware component which is subluxed inferiorly by approximately half the patella width.The patella hardware is also slightly tilted with the proximal portion positioned posteriorly and the inferior portion tilted anteriorly.This results in likely metal on metal contact between the patella and femoral component.There is small joint effusion.A definitive root cause was unable to be determined.Concomitant medical devices: unknown tibial component catalog #: ni lot #: ni, unknown femoral component catalog #: ni lot #: ni, unknown articular surface catalog #: ni lot #: ni.

Event Description

It is reported that the patient underwent a knee arthroplasty revision to address a dislodged patella and infection post-operatively.Attempts have been made and no additional information is available at this time.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION TRABECULAR METAL PRIMARY PATELLA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 10550343
• MDR Text Key: 207502213
• Report Number: 3005751028-2020-00081
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00587806538
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 184