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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP INLK PRI TIB TRAY 67MM PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VGXP XP INLK PRI TIB TRAY 67MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Lock (870); Migration or Expulsion of Device (1395)
Patient Problem Pain (1994)
Event Date 10/16/2015
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. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, ¿loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity and/or excessive weight. ¿ number 15 states, "interoperative or postoperative bone fracture and/or postoperative pain. ".

 
Event Description

It was reported that patient underwent right total knee arthroplasty on (b)(6) 2015. Subsequently, patient underwent a revision procedure on (b)(6) 2015 due to pain and the locking bar backing out approximately one inch on the medial side. The locking bar and medial and lateral bearings were removed and replaced.

 
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Brand NameVGXP XP INLK PRI TIB TRAY 67MM
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 Key5211095
MDR Text Key30775595
Report Number0001825034-2015-04579
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 10/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date01/31/2019
Device MODEL NumberN/A
Device Catalogue Number195753
Device LOT Number664260
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 Received10/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/17/2014
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: 11/09/2015 Patient Sequence Number: 1
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