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)

Patient Problem Pain (1994)

Event Date 10/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) multiple mdr reports were filed for this event, please see associated reports: mfr#0001822565-2018-00953.(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.Trabecular metal total ankle screw cat# unk lot# unk.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: 7425049
• MDR Text Key: 105271171
• Report Number: 0001822565-2018-02020
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PN/A
• 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
• 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
• Other Device ID 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: 04/12/2018
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 64