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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE G PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE G 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#:42522100913;articular surface medial congruent (mc) right 13 mm ;lot#:63364153. Item#:00587806538;nexgenâ® complete knee solution, trabecular metalâ¿¢ patella;lot#:64386822. Item#:42502806402; femur trabecular metal cruciate retaining;lot#:64507673. 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 -01914. 3005751028 -2020 -00064. 0001822565 -2020 -01912.

 
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 NameNATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING RIGHT SIZE G
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10098492
MDR Text Key195153216
Report Number0001822565-2020-01913
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK173417
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 05/29/2020
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 Number42530007902
Device LOT Number64141027
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 Received05/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/12/2019
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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