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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

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ZIMMER TMT NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 01/07/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 42502806002, femur, lot # 64278763, 42530006702, tibia, lot # 64102955, 42522100412, articular surface, lot # 63811402.

 
Event Description

It was reported that approximately 2 months post implantation, the patient was experiencing stiffness and consequently underwent a manipulation under anesthesia with injection of the right knee. Approximately 2 weeks post manipulation, the patient's swelling had reportedly resolved. Attempts have been made and no further information has been provided.

 
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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 Key9693534
MDR Text Key189025220
Report Number3005751028-2020-00011
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 06/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00587806535
Device LOT Number64245270
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 Received06/17/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/30/2019
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: 02/11/2020 Patient Sequence Number: 1
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