Device Problem
Break (1069)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 09/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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Exact date of event is unknown; september 30, 2020 is the date the literature article was published.This report is for an unknown lcp condylar plate/ unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.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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This report is being filed after the review of the following journal article: jones b.M., nugent l., griffin s.J., (2020) femoral condylar locking compression plates: a case series.The rural district general hospital experience, journal of surgical case reports, volume 9, pages 1¿5 (united kingdom) doi: 10.1093/jscr/rjaa380.This study case series aims to examine outcomes for patients managed in a rural setting.Recent insertions of condylar locking compression plates (lcps) at a rural district general hospital were examined.Between 2014 and 2019, 50 most recent distal femoral fractures comprising of 40 women and 10 men, with mean age at presentation of 77.38 years treated with the synthes 4.5/5.0 lcp condylar plate operated at ysbyty gwynedd district general hospital (dgh) (north wales) were assessed, prior to 6 months from commencing the study to allow for adequate follow-up.Average length of follow-up was 43 weeks.The following complications were reported as follows: case 4, female, screw placement too close to the fracture site has resulted in internal plate stresses exceeding its load-bearing capacity.Plate fatigue fracture prior to successful union (fig 10) inter-fragmentary screws have been utilized here.This lady may have benefited from placing an anterior bridging plate at the time of her original procedure if it was not possible to avoid this screw configuration.This report is for an unknown lcp condylar plate.This is report 5 of 8 for (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: d4: updated impacted product h3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.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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