MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BASE COMPONENT SIZE 5 GREEN FOR USE WITH SIZE 5 TALAR COMPONENTS ONLY; ANKLE PROTHESIS/EXTREMITIES

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)

Patient Problems Ossification (1428); Pain (1994)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00288, 0001822565-2022-00289, 0001822565-2022-00290.Concomitant medical products: item#: 00830002500, talar component size 5 right green for use with size 5 tibial components only, lot#: 63364413.Item#: 00830005500, tibial insert component size 5 green plus (+) 0 mm thickness for use with size 5 talar components only for export only not for distribution in the u.S, lot#: 62998251.Item#: 00235701806, distal lateral fibular plate left 6 holes 106 mm length, lot#: 63276652.Report source: foreign: event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right ankle fusion.Subsequently, the patient developed pain with ossification and impingement.The implants remain implanted and the patient is awaiting a revision surgical procedure.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Based on the information we have received it was determined that the event was not related to the implant and is no longer considered a reportable event for the this device.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00288-1.0001822565-2022-00289-1.0001822565-2022-00290-1.A patient underwent initial right ankle fusion due to progressive changes from rheumatoid arthritis, stiffness, and previous hardware that was no longer providing sufficient support to the joint.The patient initially did well after the ankle arthroplasty but showed slight increase in pain, stiffness, and swelling postoperatively which can be attributed to the patient's pre-existing comorbid conditions of rheumatoid arthritis and heterotopic ossification.The ossification and rheumatic changes in the joint led to medial gutter impingement causing mild occasional pain and tenderness.Heterotopic ossification is the abnormal and rapid growth of bone that forms within soft tissue as the result of heredity, trauma, or diseases of a joint.The rapid and irregular growth of bone often causes a sharp or jutted structure to form, causing pain and irritation to the surrounding tissues.The only treatment is surgical excision or shaving down to smooth out the excess bone.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.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.

• Brand Name: TIBIAL BASE COMPONENT SIZE 5 GREEN FOR USE WITH SIZE 5 TALAR COMPONENTS ONLY
• Type of Device: ANKLE PROTHESIS/EXTREMITIES
• 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 Key: 13451152
• MDR Text Key: 285322437
• Report Number: 0001822565-2022-00287
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00830004500
• Device Lot Number: 63086310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White