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Catalog Number 10208102 |
Device Problem
Break (1069)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A physician reported a cadence talar dome with broken pegs.The patient presented with pain and x-rays confirmed the broken pegs.According to the physician: " the integration of the pegs is very fast and solid.If the posterior part does not integrate as fast as the pegs, it might produce micro movements and a leverage effect on the pegs.Revision will be necessary as the patient has a lot of pain.".
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Event Description
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N/a.
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Manufacturer Narrative
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Complaint sample was not returned for evaluation; however, x-rays were provided and evaluated: device history records: the lot records were reviewed and no problems were identified that could have caused or contributed to the complaint.Failure analysis - the part has not yet been returned to integra for investigation, but x-ray images were provided.Evaluation of the x-ray image shows that a peg of the talar dome was broken off from the talar dome at the point where the peg joins the dome.The failure was confirmed.As the part has not yet been returned, a definitive root cause cannot be determined.According to risk management documentation for the cadence total ankle system, there are several identified failure modes which could result in breakage of the talar dome, including inadequate design and incorrect or inadequate surgical technique.If the part is later returned this complaint may be reopened and an analysis performed.
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Manufacturer Narrative
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Updated fields: a2, g3, g6, h2, h3, h6, h10.Additional information received: - the patient is a 80 year-old.- the revision surgery is not planned yet.The patient did not suffer any trauma/accident that caused the failure.
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Event Description
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N/a.
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Manufacturer Narrative
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Additional information received: the dysfunction was observed 31 months after implantation.Implant extraction is not planned as patient is asymptomatic.
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Event Description
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N/a.
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Search Alerts/Recalls
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