Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Seroma (2069)
|
Event Date 10/29/2021 |
Event Type
Injury
|
Event Description
|
This complaint is from a literature source.The following literature cite has been cintean r, pankratz c, hofmann m, gebhard f, schütze k.Early results in non-displaced femoral neck fractures using the femoral neck system.Geriatr orthop surg rehabil.2021 oct 29;12:21514593211050153.Doi: 10.1177/21514593211050153.Pmid: 34733579; pmcid: pmc8559200.Objective and methods: the purpose of this study is to compare the outcome of 63 elderly patients with multiple comorbidities presenting with undisplaced femoral neck fractures that were treated with 34 depuy corail/bipolar hemiarthroplasties (ha) or 29 synthes fns between june 2018 and june 2020.This complaint will capture the events associated with the depuy ha.The events associated with the synthes fns are captured separately.All events associated with the patient¿s preexisting comorbidities are excluded from the complaint.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: depuy hemiarthroplasty consisting of a corail stem and an unspecified depuy self-centering bipolar femoral head.Adverse event(s) and provided interventions associated with depuy devices: 3 seromas: 2 treated with revision and 1 treatment unspecified.1recurrent dislocation treated with conversion to tha.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|
|