MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 125 DEG 11MM X 180MM EXTREMITIES, IMPLANT

Model Number N/A

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

Patient Problem Reaction (2414)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: item# 814550042; cortical bone scr 5. 0 mm x 42 mm; lot# dpnbmy, item# 814510105; hfn lag screw 10. 5 mm x 105 mm; lot# vf1112305d, item# 281001100; ball nose guide wire 100 cm; lot# 203690. Report source: foreign: event occurred in (b)(6). 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 mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04268, 0001825034-2019-04272. Remains implanted.

Event Description

It was reported that the certificate with the material composition was requested post surgery due to possible intolerance. Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: HFN 125 DEG 11MM X 180MM
• Type of Device: EXTREMITIES, IMPLANT
• 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: 9135360
• MDR Text Key: 163038483
• Report Number: 0001825034-2019-04273
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 814311180
• Device Lot Number: 968030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2018
• 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 Treatment Data

Date Received: 09/30/2019 Patient Sequence Number: 1