Model Number 1035-40-000 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Anemia (1706); Edema (1820); Hematoma (1884); Pain (1994); Seroma (2069); Joint Dislocation (2374); No Code Available (3191)
|
Event Date 12/09/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(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 received implant unknown hip side on (b)(6) 2019.Revision on (b)(6) 2019 because of pain and luxation.The pe ring was found to be fractured.Further details unknown at the moment.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).
|
|
Manufacturer Narrative
|
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. patient code: no code available (3191) used to capture device revision or replacement.
|
|
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.Product complaint # (b)(4).Investigation summary : following review of the information received, it was concluded that it was unlikely that a product issue as a result of the manufacture or design was present.The complaint shall be closed with an unjustified conclusion, it shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
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. additional narrative:.
|
|
Search Alerts/Recalls
|