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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG ROD, FIXATION

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ZIMMER BIOMET, INC. AFFIXUS HFN 125 DEG ROD, FIXATION Back to Search Results
Catalog Number 814313180
Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 01/31/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). It is unknown if product will be returning to 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 the patient underwent a hip fracture nail revision due to unknown reasons.
 
Manufacturer Narrative
If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the patient was revised due to implant fracture.
 
Manufacturer Narrative
If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameAFFIXUS HFN 125 DEG
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8549426
MDR Text Key143060308
Report Number0001825034-2019-01877
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number814313180
Device Lot Number123690
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/05/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/25/2019 Patient Sequence Number: 1
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