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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH LOCKING SCREW; PROSTHESIS, KNEE
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ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH LOCKING SCREW; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Patient Involvement (2645)
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 by the distributor the product arrived damaged with sterility barrier potentially compromised.There was no patient involvement.
 
Manufacturer Narrative
It was determined the sterility of this device was not compromised.This event is not a reportable malfunction.Please void this submission.
 
Event Description
It was determined the sterility of this device was not compromised.This event is not a reportable malfunction.Please void this submission.
 
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Brand Name
ARTICULAR SURFACE WITH LOCKING SCREW
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8470062
MDR Text Key140501642
Report Number0001822565-2019-01338
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
PMA/PMN Number
K003910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 08/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model NumberN/A
Device Catalogue Number90595203020
Device Lot Number64118255
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/06/2019
Initial Date FDA Received04/01/2019
Supplement Dates Manufacturer Received08/15/2019
Supplement Dates FDA Received09/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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