MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL TOTAL ANKLE SCREW; PROSTHESIS, ANKLE

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 10/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Concomitant medical products: tibial insert component size 3 blue plus cat#: 00830005300, lot#: 63090112, tibial base component cat#: 00830004300, lot#: 63096504, talar component cat#: 00830001300, lot#: 63112686, one- third tubular plate with collar 9 holes cat#: 00493500903, lot#: 63518815.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as 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.Product location is unknown.

Event Description

It was reported that the patient had painful screw heads of medial ankle after initial right total ankle procedure.No intervention has been reported to date.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.

Event Description

It was reported that the patient had painful screw heads of medial ankle after initial left total ankle procedure.No intervention has been reported to date.

Manufacturer Narrative

(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.Reported event was confirmed by review of x-rays provided.X-ray review show loosening and breakage of the 2 syndesmotic screws, with syndesmotic screws backing out by several millimeters and syndesmotic screw heads no longer flush with the plate.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history review cannot be performed without product identification.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

Event Description

It was reported that the patient had painful screw heads of medial ankle after initial left total ankle procedure.X-rays revealed loosening and fracture of 2 syndesmotic screws as well as backing out by several millimeters preventing the screw heads from being flush with the plate.No intervention has been reported to date.

• Brand Name: TRABECULAR METAL TOTAL ANKLE SCREW
• 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: 7304363
• MDR Text Key: 101233811
• Report Number: 0001822565-2018-00953
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNI
• 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,Followup
• Report Date: 04/05/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 02/14/2018; 03/23/2018
• Supplement Dates FDA Received: 03/14/2018; 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 64