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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Thrombosis (2100)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation; as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. (b)(4). Concomitant medical products: nexgen poly patella item # 00597206535 lot # 64080689. Nexgen tibial component item # 0059860701 lot # 64069081. Nexgen articular surface item # 90597005010 lot # 64000448. Unknown refobacin cement. Report source: foreign - (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00183, 0002648920-2019-00184, 0001822565-2019-01087. 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.

 
Event Description

It was reported that the patient underwent a knee arthroplasty. Subsequently, approximately seven days post-implantation the patient had a cardiac arrhythmia, deep vein thrombosis (dvt).

 
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Brand NameNEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING CR-FLEX FEMORAL COMPONENT
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 Key8419672
MDR Text Key138759777
Report Number0001822565-2019-01086
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeDA
PMA/PMN NumberK031061
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,S
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00595201701
Device LOT Number64134254
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 Received11/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/22/2018
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: 03/14/2019 Patient Sequence Number: 1
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