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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RM 9X71 PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VGXP XP E1 TIB BRG RM 9X71 PROSTHESIS, KNEE Back to Search Results
Catalog Number 195402
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Pain (1994)
Event Date 11/11/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical product: vngd xp inlk pri tib tray, catalog # 195249, lot # 373020; vgxp xp e1 tib brg rl, catalog # 195332, lot # 514980; vgxp intlk fmrl rt, catalog # 195206, lot # 503630. 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: 0001825034-2018-05932, 0001825034-2018-05945, 0001825034-2018-05957. Remains implanted.

 
Event Description

It was reported that the patient underwent a right knee arthroplasty. Subsequently, the patient suffered burning knee pain which was treated with aspiration and an injection. Attempts have been made and additional information on the reported event is unavailable. No additional patient consequences were reported.

 
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Brand NameVGXP XP E1 TIB BRG RM 9X71
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 Key7759474
MDR Text Key116363880
Report Number0001825034-2018-05998
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK122160
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 01/03/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue Number195402
Device LOT Number663070
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 Received12/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/08/2013
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: 08/07/2018 Patient Sequence Number: 1
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