WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED,
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Model Number 33630022 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Tissue Damage (2104)
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Event Date 01/03/2017 |
Event Type
Injury
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Manufacturer Narrative
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Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Event Description
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Allegedly, it was reported that the patient was scheduled for a calcaneal osteotomy.It was reported that during incision, it was discovered the patient could possibly have an infection.Tissue cultures confirmed the infection, so all of the ankle replacement implants were removed from the patient.The implant appeared to "stuck" to the patient's bone.Therefore, the bone was peeled off of the talus and tibial components.Surgeon created an antibiotic cement spacer.No additional patient complications were reported.
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Manufacturer Narrative
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The parts were returned for evaluation.Overall, the poly insert and tibial tray did not show any gross deformation.Visual examination of all the devices showed a few gouge marks and heavier scratches/dings, which are consistent with removal during the revision surgery.Visual examination the porous surface of the talar dome and tibial tray does exhibit a few areas of apparent bone attachment.Finally, examination of the talar dome found that some of the plasma spray is missing.
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Search Alerts/Recalls
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