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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD DCM CR TIBIAL BEARING 12MM X 71/75MM PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VANGUARD DCM CR TIBIAL BEARING 12MM X 71/75MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 03/10/2015
Event Type  Injury  
Manufacturer Narrative
3 of 5. Reference mfr. Reports: 0001825034-2017-00810; 0001825034-2017-00812; 0001825034-2017-00815; 0001825034-2017-00817. Concomitant medical products: item: 3003940002, refobacin bone cement r 40x2, lot: a350aj2914. Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.
 
Event Description
It was reported the patient underwent a left knee arthroplasty. Approximately 4 months post-implantation the patient experienced an infection which resulted in medical intervention during which the patient's joint was rinsed and 4 days later the patient's implants were explanted and replaced.
 
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Brand NameVANGUARD DCM CR TIBIAL BEARING 12MM X 71/75MM
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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6352238
MDR Text Key68087474
Report Number0001825034-2017-00813
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
PK113550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Model NumberN/A
Device Catalogue Number183442
Device Lot Number168890
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 Received01/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
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: 02/23/2017 Patient Sequence Number: 1
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