Catalog Number 33680014 |
Device Problems
Device Dislodged or Dislocated (2923); Osseointegration Problem (3003); Migration (4003)
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Patient Problems
Cyst(s) (1800); Fall (1848); Inadequate Osseointegration (2646); Limb Fracture (4518)
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Event Date 01/11/2024 |
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.H3 other text : device remains implanted in patient.
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the tibial component.It was reported that the patient fell and fractured tibia and dislodged and migrated tibial component.Patient claims it was not due to a fall or noncompliance.After reviewing post-op x-rays and current x-rays, the physician believes patient did in fact fall or was noncompliant.
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Event Description
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The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the tibial component.It was reported that the patient fell and fractured tibia and dislodged and migrated tibial component.Patient claims it was not due to a fall or noncompliance.After reviewing post-op x-rays and current x-rays, the physician believes patient did in fact fall or was noncompliant.
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Manufacturer Narrative
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Correction - h6 (device code) the reported event could be confirmed, based on available medical records and health care professionals.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.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing hcp opinion and surgeon¿s feedback we can conclude that the tibial component shows some radiolucence and some cysts.It is subsidence anteriorly.Loosening and migration could be confirmed.Pe seems attached with components, no sign of breakage or separation.The talar component shows some radiolucence.Loosening is likely possible.There is no clear evidence of migration.Based on investigation, the root cause was attributed to a patient related issue.The patient falling and/or patient non-compliance has been indicated by treating surgeon in this event.The failure is detected by the radiolucence and subsidence of tibial components and radiolucency around talar component.If device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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