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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)

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.

Event Description

No further information available at the time of this reporting.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: TM ANKLE TIBIAL INSERT COMPONENT SIZE 5 GREEN PLUS (+) 0 MM THICKNESS
• Type of Device: PROSTHESIS, ANKLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8004869
• MDR Text Key: 124991510
• Report Number: 0001822565-2018-05889
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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 Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00830005500
• Device Lot Number: 62779362
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82