• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER TMT NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Information (3190)
Event Date 10/05/2015
Event Type  Injury  
Manufacturer Narrative

(b)46. A hcp reviewed provided rdc report and identified that the patient reported feeling popping in the right knee and states that the implant feels loose. No pain was identified. Surgeon was uncertain if this was device related. Review of the device history record did not identify any deviations or anomalies during manufacturing. A definitive root cause was not 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. Concomitant medical product(s): 42500606602, femur cemented posterior stabilized (ps) standard right size 9, lot 62701774; 42530007902, natural tibia trabecular metal two-peg porous fixed bearing right size g, lot 62620499; 42521400910, articular surface fixed bearing posterior stabilized (ps) right 10 mm height, lot 62064336.

 
Event Description

It was reported that approximately 1 year post implantation, the patient was experiencing a popping noise in knee, as well as alleged loosening. Attempts have been made and no further information has been provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA
Type of DevicePROSTHESIS, 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 Key9990762
MDR Text Key191915414
Report Number3005751028-2020-00027
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,STUDY
Reporter Occupation
Type of Report Initial
Report Date 04/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device MODEL NumberN/A
Device Catalogue Number00587806535
Device LOT Number62602728
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/07/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/23/2020 Patient Sequence Number: 1
-
-