MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DIST TIB ANTLAT RT NRW 6H STE; PLATE, FIXATION

Catalog Number 856202006

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

Patient Problem Numbness (2415)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

It was reported that the patient had numbness over the dorsal side of the foot.There has been no reported medical intervention.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g7, h1, h2, h10 clinical study patient underwent placement of alps plating system on (b)(6) 2019.It was reported patient experienced an episode of numbness on the dorsal aspect of foot on (b)(6) 2019.Alteration in sensation can be associated with different factors such as patient comorbidities, trauma to the area, as well as placement of surgical implant.Limited patient information was provided and it was reported patient tolerated reported event without medical or surgical intervention being performed, patient remains implanted, and no serious injury is identified; thus, not reportable event.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.

• Brand Name: DIST TIB ANTLAT RT NRW 6H STE
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): .; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13055194
• MDR Text Key: 284022970
• Report Number: 0001825034-2021-03395
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111663
• 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: 01/11/2022

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: 856202006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/11/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose