MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM NAIL RETRO 10.5MM X 420MM; ROD, FIXATION

Catalog Number 14-444242

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

Patient Problem Unequal Limb Length (4534)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign: (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the patient underwent a revision procedure due to leg length discrepancy.It is unknown if the procedure was related to the implant.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: FEM NAIL RETRO 10.5MM X 420MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11752575
• MDR Text Key: 248400610
• Report Number: 0001825034-2021-01326
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K072161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14-444242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• 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