• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIB BRG RM 9X71 PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS VGXP XP E1 TIB BRG RM 9X71 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 07/06/2015
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 6 states, "inadequate range of motion due to improper selection or positioning of components. " this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2016-00903 / 00904).

 
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 stiffness. The bearings were removed and replaced.

 
Manufacturer Narrative

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

 
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 stiffness. During the procedure, bearings were implanted and removed due to a sizing issue. Another set of bearings were used to complete the procedure.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVGXP XP E1 TIB BRG 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 Key5505814
MDR Text Key40522948
Report Number0001825034-2016-00904
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2016
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 Number195849
Device LOT Number157660
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 Received03/24/2016
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: 03/16/2016 Patient Sequence Number: 1
-
-