EXACTECH, INC. OPTETRAK UNICONDYLAR TIBIAL COMPONENT, ALL-POLY LEFT MEDIAL/RIGHT LATERAL
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Catalog Number 252-12-05 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 01/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Index surgery: (b)(6) 2016.In (b)(6) 2017, patient presented with increased pain and swelling in the left knee, possible chondromalacia.Patient is also having difficulties with her right knee that had a replacement, which is causing her left knee to compensate.Actions taken: medication, steroid injection, ice and elevation.The adverse event form indicates this event is definitely not related to devices.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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The patient has a comorbidity of obesity; one contraindication for the use of this product states weight, age, or activity level might cause extreme loads and early failure of the system.This patient has bilateral knee replacement, which indicates a history of chronic knee pain and treatments.The knee systems are contraindicated in the following situations: · patients with suspected or confirmed systemic infection or a secondary remote infection · patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis · patients without sufficient soft tissue integrity to provide adequate stability · patients with either mental or neuromuscular disorders that do not allow control of the knee joint · patients whose weight, age, or activity level might cause extreme loads and early failure of the system.Event date was reported as (b)(6) 2017.
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Event Description
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Associated mfrs for this event: 103867-2017-00266, 103867-2017-00267, 103867-2017-00268, 103867-2017-00269, and 103867-2017-00270.
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Search Alerts/Recalls
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