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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 30MM; HIP PROSTHESIS
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ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 30MM; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the inspection member at the warehouse found no patient label in the package.Attempts have been made and no further information has been provided.
 
Event Description
Upon further investigation and evaluation, it was found the malfunction associated with this device has not been previously reported as resulting in serious injury.This mdr is being written to relay that this complaint is not reportable.
 
Manufacturer Narrative
Upon further investigation and evaluation, it was found the malfunction associated with this device has not been previously reported as resulting in serious injury.This mdr is being written to relay that this complaint is not reportable.
 
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Brand Name
G7 SCREW 6.5MM X 30MM
Type of Device
HIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8468810
MDR Text Key142340864
Report Number0001825034-2019-01488
Device Sequence Number1
Product Code PBI
Combination Product (y/n)N
PMA/PMN Number
K121874
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number010000999
Device Lot Number6478742
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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