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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE TIBIAL BASE SIZE 4 PROSTHESIS, ANKLE
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ZIMMER BIOMET, INC. TM ANKLE TIBIAL BASE SIZE 4 PROSTHESIS, ANKLE Back to Search Results
Catalog Number 00450004400
Device Problem Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
 
Event Description
It was reported that patient underwent ankle procedure on an unknown date. Subsequently, patient has reported ongoing pain and impingement issues. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameTM ANKLE TIBIAL BASE SIZE 4
Type of DevicePROSTHESIS, ANKLE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10909127
MDR Text Key218497852
Report Number0001822565-2020-03873
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00450004400
Device Lot Number64199805
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 11/26/2020 Patient Sequence Number: 1
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