Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Fracture (1260)
|
Patient Problems
No Code Available (3191); Insufficient Information (4580)
|
Event Date 12/31/2018 |
Event Type
Injury
|
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.
|
|
Event Description
|
The literature article entitled, "risk factors for femoral stem breakage: an analysis of the aoanjrr results" published by hip internation accepted by publisher on 31 december 2018 was reviewed.The article's purpose was to study risk factors for stem breakage.Data was compiled from 143 stem breakages overa period of 16 years of over 44 different stem designs.Depuy stems were listed amongst non-depuy.Depuy product(s): c-stem (qty 6), corail (qty 9), srom (qty 8), solution (qty 1), summit (qty 1), trilock (qty 1).Adverse event: revisions due to stem (component) breakage.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no devices associated with this report were received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|