Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bone Fracture(s) (1870); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
|
Event Date 10/30/2019 |
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.No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
|
|
Event Description
|
Surgeon had a patient with a 40 mm bipolar head and 40 mm +4 10 degree liner in situ.He had to remove the self centering bipolar head because the poly insert in the head¿s rim that clips into big metal head, broke.
|
|
Event Description
|
Additional information received that the patient experienced pain and immobility.There was no surgical delay and when patient presented with pain and immobility, surgeon had x-rays done and saw the position of the femoral head implant was altered and decided to have it revised.The affected side was the right hip and the date of implantation was 2018.
|
|
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. h10 additional narrative: added: a1, b5, h6 (patient code).
|
|
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.H10 additional narrative: corrected:h6(device) product complaint # (b)(4).Investigation summary - no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot - null.Device history batch - null.Device history review - null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|