DEPUY ORTHOPAEDICS, INC. 1818910 SELF CENT HIP 46X28 BRN; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
|
Back to Search Results |
|
Catalog Number 103546000 |
Device Problem
Fitting Problem (2183)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/19/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).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.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.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 polyethelyne was loose in the bipolar head upon unboxing the implant.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: updated: (b)(4), 2019.The device has been returned for examination.Examination of the returned device components is unable to confirm the reported problem.The components can be assembled as intended with no excess movement.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
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. .
|
|
Search Alerts/Recalls
|
|
|