• 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 BIOMET MODULAR TIBIAL LOCKING BAR TI 6 AL 4V ALLOY 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 BIOMET MODULAR TIBIAL LOCKING BAR TI 6 AL 4V ALLOY 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
Four of 5. Reference mfr. Reports: 0001825034-2017-00810, 0001825034-2017-00812, 0001825034-2017-00813, 0001825034-2017-00817. Concomitant product medical product: 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIOMET MODULAR TIBIAL LOCKING BAR TI 6 AL 4V ALLOY
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 Key6352240
MDR Text Key68087319
Report Number0001825034-2017-00815
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
PK063732
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 Model NumberN/A
Device Catalogue Number141205
Device Lot Number172580
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 Manufactured10/25/2014
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
-
-