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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 20MM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. G7 SCREW 6.5MM X 20MM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source: (b)(6).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 during inspection a stain on the sterile package was found.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that the packaging defect does not affect form, fit, function, or sterility of the device.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that the packaging defect does not affect form, fit, function, or sterility of the device.The initial report was forwarded in error and should be voided.
 
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Brand Name
G7 SCREW 6.5MM X 20MM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8453220
MDR Text Key139891834
Report Number0001825034-2019-01279
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 distributor,foreign
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number010000997
Device Lot Number6484945
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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