• 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 TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES INSTRUMENT, 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 TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Difficult To Position (1467)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was not returned for evaluation examination of the reported device was not possible as it was not returned. Visual and dimensional evaluations could not be performed. A review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event; the device is considered to have met its specifications at the time it was sent to distribution. The investigation can draw no conclusions with the information made available. Based on the inability to determine root cause, the need for corrective, preventative, or field action(s) have not been indicated as a result of this investigation. Zimmer biomet considers the investigation closed at this time. If any further information is found which would change or alter any conclusions or information, a follow-up report will be filed accordingly. Not returned to manufacturer.
 
Event Description
It was reported that a patient underwent right partial knee arthroplasty. During the procedure the surgeon noted that it was not easy to position the tibial cut guide and the vertical cut was made severely to the lateral side of the guide.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES
Type of DeviceINSTRUMENT, 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 Key6816909
MDR Text Key83502286
Report Number0001825034-2017-06755
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 08/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number42539905285
Device Lot Number63512100
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 Received03/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/24/2017 Patient Sequence Number: 1
-
-