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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Damage to Ligament(s) (1952); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Attempts have been made and additional information on the reported event is unavailable at this time. It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: nexgen tibial tray item # unknown lot # unknown, nexgen bearings item # unknown lot # unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00745, 0001822565-2019-00746. 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 a patient underwent left knee arthroplasty on an unknown date; subsequently, the patient is being considered for a revision on an unknown day for an unknown reason.

 
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Brand NameNEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX
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 Key8354738
MDR Text Key136718285
Report Number0001822565-2019-00744
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00596201551
Device LOT Number62086782
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 Received09/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/13/2012
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: 02/20/2019 Patient Sequence Number: 1
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