MAUDE Adverse Event Report: ZIMMER TMT COMPLETE KNEE SOLUTION, TM STANDARD PRIMARY PATELLA

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification.The deep vein thrombosis is being treated with anticoagulation as per the reporting information.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.Remains implanted.

Event Description

It was reported that a patient underwent an initial knee procedure on (b)(6) 2017.Deep vein thrombosis was found 6 days after operation.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: pn#: 42500806202, trabecular metalâ¿¢ posterior stabilized monoblock tibial component: green, size 5 e-f, 10mm, lot#: 63208575 pn#: 42500806202, femur trabecular metal posterior stabilized (ps) standard porous, lot#: 63680778.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is determined to be procedure related and unrelated to the devices.

• Brand Name: COMPLETE KNEE SOLUTION, TM STANDARD PRIMARY PATELLA
• Type of Device: TM STANDARD PRIMARY PATELLA
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 7169491
• MDR Text Key: 96577472
• Report Number: 3005751028-2018-00002
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00587806535
• Device Lot Number: 63695060
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 98