SYNTHES GMBH RADIAL HEAD W/ Ø25MM HD, Ø7.5MM STM,11(+0)MM HD HT,STER; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
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Catalog Number 09.405.570S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Contracture (4528)
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Event Type
Injury
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Event Description
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This report is related to data use agreement (dua) which includes safety related data on synthes radial head replacement (rhr) system.It was reported that the patient underwent primary replacement after fracture of the radial head.Postoperative complication reported as persistent elbow contracture with heterotrophic ossification which was to be mitigated via capsular release and hardware removal of ulna plate (rhr implant was not removed).This report is for one (1) radial head w/ ø25mm hd, ø7.5mm stm,11(+0)mm hd ht,ster this is report 1 of 6 for complaint (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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