Catalog Number 00450004600 |
Device Problems
Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395); Malposition of Device (2616)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)
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Event Date 10/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It is reported the patient was revised due to the tibial component being loose.
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Manufacturer Narrative
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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 4 of 4 mdrs filed for the same patient (reference 1822565 -2016 -04286/04287/04036).
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch, and corrected information.
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Event Description
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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.
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Search Alerts/Recalls
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