MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT; ANKLE PROSTHESIS

Catalog Number 00450004600

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Skin Irritation (2076)

Event Date 05/12/2016

Event Type  Injury  

Event Description

It is reported that the patient underwent an open reduction and internal fixation procedure of the ankle due to periprosthetic fracture two months post-operatively.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.No devices or photos were returned for evaluation.The device history records were reviewed for the ankle talus and ankle tibial with no deviations or anomalies being identified.This device is used for treatment.Surgical technique and notes were not provided.A definitive root cause of the reported issue cannot be determined.This report is number 2 of 4 mdrs filed for the same patient (reference 1822565 -2016 -04286/04036/04037).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, as well as corrected information.

Event Description

It is reported that the patient underwent an open reduction and internal fixation procedure of the ankle due to periprosthetic fracture two months post-operatively.Operative notes received states the patient had some superficial sloughing skin laterally over the hardware due to the patient becoming weight bearing in their walking boot, and an insufficiency fracture due to possible over resection of the medial malleolus from the implant.Possible infection was also noted.An irrigation and debridement was performed, as well as placement of a fixation plate to correct the peri-prosthetic fracture.

• Brand Name: ZIMMER TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
• Type of Device: ANKLE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6117099
• MDR Text Key: 60545571
• Report Number: 0001822565-2016-04287
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK120906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 00450004600
• Device Lot Number: 62248811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2017; 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 118