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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TALAR COMPONENT SIZE 2 RIGHT YELLOW FOR USE WITH SIZE 2 TIBIAL COMPONENTS ONLY ANKLE, PROSTHESIS

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ZIMMER BIOMET, INC. TALAR COMPONENT SIZE 2 RIGHT YELLOW FOR USE WITH SIZE 2 TIBIAL COMPONENTS ONLY ANKLE, PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Report source: foreign: (b)(4). Concomitant medical products: tibial base component, cat: 00830004200, lot: 64136441. Tibial insert component, cat: 00830005200, lot: 64056132. 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 report will be submitted.

 
Event Description

It was reported that the patient was revised approximately one year post-implantation due to infection. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameTALAR COMPONENT SIZE 2 RIGHT YELLOW FOR USE WITH SIZE 2 TIBIAL COMPONENTS ONLY
Type of DeviceANKLE, PROSTHESIS
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 Key9677238
Report Number0001822565-2020-00502
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00830002200
Device LOT Number63744029
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 Received04/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/09/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/06/2020 Patient Sequence Number: 1
Treatment
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