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U.S. Department of Health and Human Services

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

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BIOMET ORTHOPEDICS VANGUARD XP E1 TIBIAL BEARING RM 9X71 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Arthritis (1723); Hypersensitivity/Allergic reaction (1907); Pain (1994); Complaint, Ill-Defined (2331)
Event Date 05/07/2015
Event Type  Injury  
Event Description

It was reported that patient underwent an initial right total knee arthroplasty on (b)(6) 2014. Subsequently, patient was revised on (b)(6) 2015 due to pain from poly sensitivity. Review of radiographs revealed, arthritis with early loss of joint space, sclerosis and mild spurring. The tibial bearing and tibial tray were removed and replaced.

 
Event Description

It was reported that patient underwent an initial right total knee arthroplasty on (b)(6) 2014. Subsequently, patient was revised on (b)(6) 2015 due to synovitis with pain. Review of radiographs revealed arthritis with early loss of joint space, sclerosis and mild spurring. The tibial bearing and tibial tray were removed and replaced.

 
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 15 states, "postoperative pain". This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02314 / 02315).

 
Manufacturer Narrative

The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.

 
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Brand NameVANGUARD XP E1 TIBIAL BEARING RM 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 Key4805217
MDR Text Key5831004
Report Number0001825034-2015-02314
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 06/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/31/2019
Device MODEL NumberN/A
Device Catalogue Number195849
Device LOT Number700870
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/03/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/18/2014
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: 05/29/2015 Patient Sequence Number: 1
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