WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNKNOWN RADIAL HEAD PROSTHESIS; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
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Device Problem
Device Slipped (1584)
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Patient Problems
Fatigue (1849); Pain (1994); Loss of Range of Motion (2032)
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Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown radial head/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is an attorney.Without a lot number the device history records review could not be completed.Product was not returned.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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Event Description
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It was reported that a patient was implanted with depuy synthes radial head implant system on or about (b)(6) 2016.Postoperatively patient experienced pain, loss of range of motion, and weakness in patient's left elbow.X-rays and ct scan taken on or about (b)(6) 2020 confirmed loosening of the radial stem implant.The patient underwent the revision surgery on or about (b)(6) 2020 and during removal procedures the surgeon found out that radial head stem to be loose.No further information provided.This report is for one (1) unknown radial head.This is report 2 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).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.H10 additional narrative: b6: updated tests/lab data.B7: updated medical history.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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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