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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TIBIAL RESEC HEAD-LEFT W/ALIG GAUGE, DEPTH

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BIOMET ORTHOPEDICS TIBIAL RESEC HEAD-LEFT W/ALIG GAUGE, DEPTH Back to Search Results
Model Number N/A
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2017
Event Type  malfunction  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. A summary of the investigation has been sent to the complainant.
 
Event Description
It is reported that the instrument would not seat properly and that the cut and axis were not accurate.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Investigation of this incident is currently ongoing. A follow-up/final report will be submitted when additional information becomes available.
 
Manufacturer Narrative
No devices were received with this complaint; therefore the condition of the components is unknown. Review of device history records could not be completed as lot identification was not provided. A compatibility check could not be performed with limited device information. This device is used for treatment. Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. No corrective actions, preventive actions, or field actions resulted after investigation of this event. The root cause could not be determined with the information provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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Brand NameTIBIAL RESEC HEAD-LEFT W/ALIG
Type of DeviceGAUGE, DEPTH
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 Key6352684
MDR Text Key130078827
Report Number0001825034-2017-00883
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32-487556
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 Received06/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

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