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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP RIGHT MEDIAL BEARING 9MM X 79/83MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VANGUARD XP RIGHT MEDIAL BEARING 9MM X 79/83MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Swelling (2091); Thrombosis (2100)
Event Date 04/24/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Udi #: (b)(4). Concomitant medical products ¿ vanguard xp right lateral bearing 9mm x 79/83mm catalog #: 195786 lot #: 776680, vanguard series-a thin patella 34mm catalog #: 184786 lot #: 415080, vanguard xp femoral component right with pegs 72. 5mm catalog #: 195913 lot #: 378570, vanguard xp interlok primary tibial tray 79mm catalog #: 195758 lot #: ni. Report source: report source. The complainant 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. Multiple mdr reports were filed for this patient; please see all reports associated with this event. 0001825034-2019-04322, 0001825034-2019-04323, 0001825034-2019-04324, 0001825034-2019-04325, 0001825034-2019-04326. Investigation incomplete.

 
Event Description

It is reported that the patient had developed leg swelling, deep vein thrombosis and minor erythema eight (8) days following knee arthroplasty. The patient was treated with elevation and twenty-four (24) hours of antibiotics. No additional patient consequences were reported.

 
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Brand NameVANGUARD XP RIGHT MEDIAL BEARING 9MM X 79/83MM
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 Key9129586
MDR Text Key160493689
Report Number0001825034-2019-04322
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/23/2019
Device MODEL NumberN/A
Device Catalogue Number195856
Device LOT Number803960
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/23/2014
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: 09/27/2019 Patient Sequence Number: 1
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