MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM ANKLE ADJUSTABLE U-FRAME; PROSTHESIS, ANKLE

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a total ankle replacement surgery, the frame bent and did not work properly.This caused a 60 minute delay during the surgery.The surgery was completed using the same device.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Adjustable u-frame was returned for evaluation.Dimensions taken are within specifications.However, as the rods and base frame were not returned, a functional check cannot be performed and the complaint cannot be confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definite root cause cannot be determined with the information provided.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: TM ANKLE ADJUSTABLE U-FRAME
• Type of Device: PROSTHESIS, ANKLE
• 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: 7567177
• MDR Text Key: 110027593
• Report Number: 0001822565-2018-03043
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

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?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00450105002
• Device Lot Number: 63147329
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization