Model Number 33680033 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problems
Failure of Implant (1924); Inflammation (1932); Foreign Body In Patient (2687); Implant Pain (4561)
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Event Date 12/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that the patient presented with progressive pain and swelling over one year post-op from infinity total ankle replacement.The physician noticed the broken pegs upon getting a ct for the patient.A revision arthroplasty was performed.During the revision, both the tibial and talar peg were broken off into the patient's bone.
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.¿ the device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert, and he opined that- ¿the pre-(revision)-operative breakage of the tibial peg can neither be confirmed or excluded.The background information to the x-ray is also missing.It is not clear at what time point it has been taken.A thin layer of radiolucency tibial and a very little radiolucency around the talar component is visible.Without further clinical information and without the other plane no sound assessment whether there is loosening or not can be given and even less an answer to the question of what the underlying cause is.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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It was reported that the patient presented with progressive pain and swelling over one year post-op from infinity total ankle replacement.The physician noticed the broken pegs upon getting a ct for the patient.A revision arthroplasty was performed.During the revision, both the tibial and talar peg were broken off into the patient's bone.
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Search Alerts/Recalls
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