MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TM ANKLE FIBULAR PLATE; PROSTHESIS, EXTREMITIES

Catalog Number UNK TM ANKLE FIBULAR PLATE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03548.Concomitant medical products: item#: unk fibular screws; report source: foreign - event occurred in italy.Report source: literature.Maccario c, paoli t, romano f, d'ambrosi r, indino c, federico ug.Transfibular total ankle arthroplasty : a new reliable procedure at five-year follow-up.Bone joint j.2022 apr;104-b(4):472-478.Doi: 10.1302/0301-620x.104b4.Bjj-2021-0167.R5.Pmid: 35360940.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported that a journal article was retrieved from foot & ankle (2022) that reported a prospective study from italy.The purpose of the study was to evaluate the five-year clinical, functional, and radiological results previously reported at two-year follow-up for the same cohort of patients who underwent transfibular total ankle arthroplasty (taa).The study reported 2 patients experienced delayed wound healing; of which, one required fibular plate removal and surgical debridement at 2 months.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 it is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression of a non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process which can be complicated by patient comorbidities such as diabetes, obesity, smoking, and other conditions that are known to slow a person¿s ability to heal.Wound complications can be treated conservatively or more invasively with an irrigation and debridement (i&d) which promotes healing at the site and prevents further complications.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNK TM ANKLE FIBULAR PLATE
• Type of Device: PROSTHESIS, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16016004
• MDR Text Key: 305827628
• Report Number: 0001822565-2022-03547
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK TM ANKLE FIBULAR PLATE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose