Device Problems
Material Erosion (1214); Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Date 12/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure may be necessary.Should additional information be received regarding a revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.
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Event Description
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It is reported that the patient is indicated for elbow arthroplasty revision due to unknown reasons.No revision procedure has been reported to date.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.
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Event Description
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Patient underwent elbow revision approximately eleven to thirteen years post-operatively due to a worn bushing.The bushing was removed and replaced.
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Search Alerts/Recalls
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