Model Number L20313 |
Device Problem
Loss of Osseointegration (2408)
|
Patient Problems
Fall (1848); Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)
|
Event Date 06/13/2020 |
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
|
Patient had a fall which caused a peri-prosthetic fracture of the femur, which resulted in the corail stem becoming loose and needing to be removed and replaced with a cemented stem from another company.The liner in the pinnacle cup was changed as well.
|
|
Event Description
|
The affected side was the right hip.
|
|
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.H10 additional narrative: 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 device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
|
|
Search Alerts/Recalls
|