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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIBIAL BEARING RL 10X63 PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VGXP XP E1 TIBIAL BEARING RL 10X63 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Code Available (3191)
Event Date 08/04/2015
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. This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-03674 / 03675).

 
Event Description

It was reported that patient underwent a right total knee arthroplasty on (b)(6) 2015. Subsequently, patient was revised on (b)(6) 2015 due to tightness and stiffness. The tibial tray and tibial bearings were removed and replaced.

 
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Brand NameVGXP XP E1 TIBIAL BEARING RL 10X63
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 Key5013523
MDR Text Key23421917
Report Number0001825034-2015-03675
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
Report Date 08/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/25/2019
Device MODEL NumberN/A
Device Catalogue Number195773
Device LOT Number529540
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 Received08/03/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2014
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: 08/19/2015 Patient Sequence Number: 1
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