WRIGHT MEDICAL TECHNOLOGY INC INVISION TIBIAL TRAY SZ 3 +4MM UNIVERSAL LONG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 60003402 |
Device Problems
Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2022 |
Event Type
malfunction
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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 was undergoing a total ankle replacement due to ankle arthritis.During the procedure it was noted that the invision tibia size 3 +4 component was connected to the size 16 base stem.All the indicators showed it was connected, then impacted into the tibia.From there the tibia component detached from the base stem.This happened three times.On the fourth time the surgeon used cement to secure in place.Additionally, it was reported; the procedure was extended however the length of the extension is unknown.
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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 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 was undergoing a total ankle replacement due to ankle arthritis.During the procedure it was noted that the invision tibia size 3 +4 component was connected to the size 16 base stem.All the indicators showed it was connected, then impacted into the tibia.From there the tibia component detached from the base stem.This happened three times.On the fourth time the surgeon used cement to secure in place.Additionally, it was reported; the procedure was extended however the length of the extension is unknown.
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Search Alerts/Recalls
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