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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEMMED CEMENTED TIBAL COMPONENT; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. PERSONA STEMMED CEMENTED TIBAL COMPONENT; PROSTHESIS, KNEE Back to Search Results
Catalog Number 42532006702
Device Problem Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported upon opening the tibial component, there were scratch marks and an unpolished appearance.A new implant was used to complete the procedure.No adverse events have been reported as a result of the malfunction.Attempts have been made, and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this cosmetic scuffs were acceptable.The initial report was forwarded in error and should be voided.
 
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Brand Name
PERSONA STEMMED CEMENTED TIBAL COMPONENT
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8482186
MDR Text Key140894672
Report Number0001822565-2019-01302
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number42532006702
Device Lot Number63775479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2019
Was the Report Sent to FDA? No
Date Manufacturer Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Weight43
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