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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP INTLK FMRL RT 65 PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VGXP INTLK FMRL RT 65 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Device Slipped (1584); Patient-Device Incompatibility (2682)
Patient Problems Toxicity (2333); Reaction (2414)
Event Date 07/17/2015
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. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions. ¿ number 4 states, "loosening, migration, or fracture of the implants can occur. " this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04024 / 04025).

 
Event Description

It was reported that patient underwent a total right knee anthroplasty on (b)(6) 2013. Subsequently, patient was revised on (b)(6) 2015 due to loosening caused by a possible metal allergy. All components were removed and replaced by titanium components.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. 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. ¿.

 
Event Description

It was reported that patient underwent a revision procedure approximately 20 months post-implantation due to tibial loosening from a possible metal allergy. Both the femoral component and tibial tray were removed and replaced with titanium components.

 
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Brand NameVGXP INTLK FMRL RT 65
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 Key5091832
MDR Text Key26352928
Report Number0001825034-2015-04024
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 STUDY
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number195205
Device LOT Number248040
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 Received07/18/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/02/2013
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: 09/21/2015 Patient Sequence Number: 1
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