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

Catalog Number 00450002600

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to the tibial component being loose.

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 notes were not provided.A definitive root cause of the reported issue cannot be determined.This report is number 3 of 4 mdrs filed for the same patient (reference 1822565 -2016 -04286/04287/04037).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch, and corrected information.

Event Description

Patient underwent an ankle arthroplasty revision procedure approximately seven months post-operatively due to loosening of the components, malpositioning, and pain.The talar and tibial base components were removed and replaced with competitor products.Operatives notes received state patient developed nonunion of the fibula osteotomy and developed a fracture of the tibia.The tibial component was noted to be grossly loose, while the talar component was more difficult to remove.The patient had experienced 10 degrees of varus collapse that was corrected during the revision procedure.

• Brand Name: TRABECULAR METAL TOTAL ANKLE TALUS
• 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: 6073606
• MDR Text Key: 58971636
• Report Number: 0001822565-2016-04036
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2016

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: 02/29/2024
• Device Catalogue Number: 00450002600
• Device Lot Number: 62572269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/18/2017; 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2014
• 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: 65 YR
• Patient Weight: 118