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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIB BRG RL 10X71 PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VGXP XP E1 TIB BRG RL 10X71 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Bearings (734); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 09/23/2015
Event Type  Injury  
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, ¿early or late postoperative infection and/or allergic reaction. ¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04299 / 04300).

 
Event Description

It was reported that patient underwent an initial right knee arthroplasty on (b)(6) 2015. Subsequently, the patient was revised on (b)(6) 2015 due to suspected infection and a i&d procedure was performed. The bearings were removed and replaced.

 
Manufacturer Narrative

Concomitant medical products: vgxp intlk femoral rt, catalog # 195911, lot # 195911; vgxp xp inlk pri tib tray, catalog # 195757, lot # 592640. This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Root cause remains undetermined. 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.

 
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Brand NameVGXP XP E1 TIB BRG RL 10X71
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5145256
MDR Text Key28056345
Report Number0001825034-2015-04299
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date05/06/2019
Device MODEL NumberN/A
Device Catalogue Number195780
Device LOT Number057810
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/06/2014
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: 10/13/2015 Patient Sequence Number: 1
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