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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE TIBIAL INSERT COMPONENT SIZE 5 GREEN PLUS (+) 0 MM THICKNESS PROSTHESIS, ANKLE

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ZIMMER BIOMET, INC. TM ANKLE TIBIAL INSERT COMPONENT SIZE 5 GREEN PLUS (+) 0 MM THICKNESS PROSTHESIS, ANKLE Back to Search Results
Model Number N/A
Device Problem Insufficient Information
Event Date 04/20/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Additional concomitant medical products: item # 00830004500, tibial base component size 5 , lot # 63028696; item # 00830002500, talar component size 5 right , lot # 62898131; item # 00235701706, distal lateral fibular plate right 6 holes 106 mm length, lot # 63301086. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 05887, 0001822565 - 2018 - 05888, 0001822565 - 2018 - 05890.

 
Event Description

It was reported that approximately 1 year post implantation of a total ankle arthroplasty, the patient had developed extreme pain and discomfort to the r ankle, and was found to have medial impingement. Mild swelling and stiffness and decreased range of motion were also noted. Patient underwent an arthroscopy and debridement. Attempts have been made and no further information has been provided.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. The following sections were update/corrected updated: reported event was confirmed by clinical notes. X-rays showed radiolucency. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. A definite root cause cannot be determined with the information provided. 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 NameTM ANKLE TIBIAL INSERT COMPONENT SIZE 5 GREEN PLUS (+) 0 MM THICKNESS
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 Key8004869
Report Number0001822565-2018-05889
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2019
Device MODEL NumberN/A
Device Catalogue Number00830005500
Device LOT Number62779362
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 Received09/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/02/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 10/25/2018 Patient Sequence Number: 1
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