Catalog Number 875704 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
Pain (1994)
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Event Date 02/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The patient was revised to address knee pain in the total knee.It was stated that, there was no patella in the patient from the first surgery.Bone scan was hot around the tibia.It was decided by the doctor that the tibia was loose at the bone to implant interface.Pressfit sigma fb tibia was pulled out and a sigma fixed bearing cemented tibia with a stem replaced the pressfit one.The patella was resurfaced at this time as well.Doi: (b)(6) 2016.Dor: (b)(6) 2018.Right knee.
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Manufacturer Narrative
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(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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