Model Number 2001-66-000 |
Device Problems
Material Deformation (2976); Material Twisted/Bent (2981); Scratched Material (3020)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
|
Event Date 09/24/2020 |
Event Type
malfunction
|
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
|
Staff have indicated femoral impactor head tips have been ¿warped¿ and scratched due to wear and tear and no longer articulate with the femoral trial heads properly.Items are no longer functional.Items have been discarded and no lot # available.No further information is available.No intra-op or patient issues.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.
|
|
Search Alerts/Recalls
|