• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER, INC. TRABECULAR METAL TOTAL ANKLE TALUS ANKLE PROSTHESIS Back to Search Results
Catalog Number 00450002600
Device Problems Failure To Adhere Or Bond; Migration or Expulsion of Device; Malposition of Device
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRABECULAR METAL TOTAL ANKLE TALUS
Type of DeviceANKLE 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 Key6073606
Report Number0001822565-2016-04036
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
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
Date FDA Received11/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00450002600
Device LOT Number62572269
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/25/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/02/2016 Patient Sequence Number: 1
-
-