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Model Number ACL TIGHTROPE RT |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091)
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Event Date 08/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device was requested for evaluation but device disposition is unknown, therefore the complainant's event could not be verified.Device history record review revealed nothing relevant to this event; no issues were found with the sterilization of this lot.This device is supplied sterile.Based on the information provided, a definitive cause for the post-operative infection could not be determined.The most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.
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Event Description
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It was reported that the patient needed to have the devices removed post-op due to infection.Original dos (b)(6) 2018 for acl with hamstring autograft.Patient is (b)(6) male, who presented with pain, redness, swelling.A culture showed staph infection and the devices were removed.
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Search Alerts/Recalls
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