Model Number L98011 |
Device Problem
Fracture (1260)
|
Patient Problem
No Code Available (3191)
|
Event Date 01/01/2020 |
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
|
It was reported that the surgery was scheduled on (b)(6) 2020 due to the breakage of the stem which was revised at the revision surgery on (b)(6) 2020.The surgeon planned to remove the broken distal end of the stem and perform orif, or to remove all of the stem.No further information is available.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary = no device associated with this report was received for examination.Examination of the provided images confirms the reported femoral stem fracture.It is known this patient sustained a major bone fracture while a competitor stem was in-situ and numerous cerclage wires were used in repair when the depuy device was implanted.The depuy stem fracture is in this area.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.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 = lot 5278921.A device manufacturing records (dhr) review was requested.The dhr analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.Device history review = a device manufacturing records (dhr) review was requested.The dhr analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.
|
|
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 device associated with this report was received for examination.Examination of the provided images confirms the reported femoral stem fracture.It is known this patient sustained a major bone fracture while a competitor stem was in-situ and numerous cerclage wires were used in repair when the depuy device was implanted.The depuy stem fracture is in this area.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.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 : lot 5278921.A device manufacturing records (dhr) review was requested.The dhr analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.Device history review : a device manufacturing records (dhr) review was requested.The dhr analysis showed an initial conformance of this product / lot with regards to its specification.There was no deviation or non-conformance.
|
|
Search Alerts/Recalls
|