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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK AFFIX NAIL TRAUMA IMPLANT

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ZIMMER BIOMET, INC. UNK AFFIX NAIL TRAUMA IMPLANT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product remains implanted.
 
Event Description
It was reported that the patient underwent an initial procedure at an unknown date. Subsequently, the patient has been indicated for a revision as the patient developed arthritis.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event. The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event. The initial report was forwarded in error and should be voided.
 
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Brand NameUNK AFFIX NAIL
Type of DeviceTRAUMA IMPLANT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9070094
MDR Text Key162082134
Report Number0001825034-2019-04038
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/11/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/16/2019 Patient Sequence Number: 1
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