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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER TMT NEXGENA COMPLETE KNEE SOLUTION, TRABECULAR METALA STANDARD PRIMARY PATELLA PROSTHESIS, KNEE

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ZIMMER TMT NEXGENA COMPLETE KNEE SOLUTION, TRABECULAR METALA STANDARD PRIMARY PATELLA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Date 03/03/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Associated products : item#:42502806402;femur trabecular metal cruciate retaining;lot#:64507673. Item#:42530007902;natural tibia trabecular metal two-peg ; lot#:64141027. Item#:42522100913;articular surface medial congruent (mc) right 13 mm ;lot#:63364153. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2020 -01912. 0001822565 -2020 -01913. 0001822565 -2020 -01914.

 
Event Description

It was reported that a patient underwent an initial right unilateral total knee arthroplasty on and subsequently, the patient developed a right lower extremity dvt approximately one week later, requiring an unknown medical intervention. The dvt was resolved approximately one month later.

 
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Brand NameNEXGENA COMPLETE KNEE SOLUTION, TRABECULAR METALA 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 Key10098488
MDR Text Key194966663
Report Number3005751028-2020-00064
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00587806538
Device LOT Number64386822
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/28/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 05/28/2020 Patient Sequence Number: 1
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