SYNTHES MONUMENT 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
|
Back to Search Results |
|
Catalog Number 04.402.008S |
Device Problem
Unintended Movement (3026)
|
Patient Problems
Failure of Implant (1924); Pain (1994); Osteolysis (2377)
|
Event Type
Injury
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.Patient initials are (b)(6).Patient weight was not provided by reporter.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.Sterility records for the reported lot/part number were also reviewed and determined to be conforming.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that the patient experienced pain and underwent explant surgery on (b)(6) 2015 as a result of the loosening of the radial head and a titanium straight radial stem implant and osteolysis.The patient had begun to experience pain and x-rays taken on an unknown date had revealed osteolysis and loosening of hardware.During the surgery, a large amount of fluid was noted in the elbow and cultures were collected.The cultures came back negative for infection.The patient was not revised with new implants.There was no surgical delay reported and the procedure was completed successfully.The patient initially underwent an open reduction and internal fixation (orif) of the elbow on (b)(6) 2014.This report is 2 of 2 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|