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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL CUT GUIDE; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. PERSONA TIBIAL CUT GUIDE; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 06/24/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
 
Event Description
It was reported that the drill pin got stuck to the device during an initial procedure.Attempt for further information has been made, but no further information has been provided.
 
Manufacturer Narrative
Upon receipt of additional information, this report will be completed under manufacturing report number 0001825034-2020-04179.
 
Event Description
Upon receipt of additional information, this report will be completed under manufacturing report number 0001825034-2020-04179.
 
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Brand Name
PERSONA TIBIAL CUT GUIDE
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10282389
MDR Text Key199511760
Report Number0001822565-2020-02530
Device Sequence Number1
Product Code HSX
UDI-Device Identifier00889024582859
UDI-Public(01)00889024582859
Combination Product (y/n)N
PMA/PMN Number
K200151
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number42539905295
Device Lot Number64768305
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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