Catalog Number 350-22-11 |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Joint Dislocation (2374); No Code Available (3191)
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Event Date 01/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Revision due to dislocation.
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Revision due to dislocation.
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Manufacturer Narrative
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This device is used for treatment not diagnosis.The surgeons who use these devices are knowledgeable with techniques and devices to provide the best surgical plan for the patient.There are no reported device malfunctions or problems, the most likely cause of the dislocation of the talar component is surgical and casting techniques.
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Event Description
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It is reported that the surgeon had some ideas on the dislocation of the talar component, ankle implants need to be "tight" and "remind" the personnel doing the casting to not lift the foot by the toes.Associated mfrs for this event: 1038671-2017-00033 & 1038671-2017-000159.
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Search Alerts/Recalls
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