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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIBIAL BEARING RL 9X71 PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VGXP XP E1 TIBIAL BEARING RL 9X71 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Bearings (734); Unstable (1667); Locking Mechanism (3083)
Patient Problem No Code Available (3191)
Event Date 04/20/2015
Event Type  Injury  
Event Description

It was reported that patient underwent right total knee arthroplasty on (b)(6) 2014. Subsequently, patient was revised on (b)(6) 2015 due to instability. The tibial bearings and locking bar were removed and replaced.

 
Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

 
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. There are warnings in the package insert that state that this type of event can occur: under warnings, it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. " this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-02072 / 02073).

 
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Brand NameVGXP XP E1 TIBIAL BEARING RL 9X71
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 Key4779422
MDR Text Key5781862
Report Number0001825034-2015-02073
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
Report Date 05/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/21/2019
Device MODEL NumberN/A
Device Catalogue Number195779
Device LOT Number291830
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/24/2014
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: 05/18/2015 Patient Sequence Number: 1
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