SYNTHES MONUMENT 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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Catalog Number 09.402.024S |
Device Problem
Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); Pain (1994); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient information is not available for reporting.Event date: unknown.Udi: (b)(4).Explant date: unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturer: (b)(4).Date of manufacture date: apr 23, 2015.Expiration date: mar 31, 2020.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.(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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It was reported that a patient was originally implanted with a synthes radial head and stem to repair an unknown fracture on an unknown date.On an unknown date, approximately three weeks prior to the date of this report, the patient presented with pain and it was identified via x-ray that the radial stem had begun to ¿halo¿ and had separated approximately 2mm from the radial head.The surgeon believes that this separation was contributing to the patient reported pain.On (b)(6) 2017, the patient was returned to the operating room where the surgeon was able to remove the implants intact and without difficulty, and the patient was revised to a competitor¿s implant.The procedure was completed successfully and with no patient harm.This report is 1 of 2 for (b)(4).
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Manufacturer Narrative
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Complaint was reviewed and determined to be a part of recall.Device was used for treatment, not diagnosis.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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