Catalog Number 121730500 |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/01/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
|
|
Event Description
|
A 30mm screw shed one of its threads.
|
|
Manufacturer Narrative
|
Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
A 30mm screw shed one of its threads.Examination of the returned device confirms the reported thread damage.The last and second to last threads have been damaged, as well as the screw head and body.The screw head hex has been stripped.Circular striations/wear on the body indicates the male threads may have been misthreaded into the female threads.The acetabular cup was not returned for examination and this cannot be confirmed.A search of the complaints databases identified no other reports against the product/lot code combination.Review of the device history records did not reveal any anomalies.No evidence was found suggesting product error was a contributing factor and the need for corrective action is not indicated.Monitor via sep-419.Depuy still considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Search Alerts/Recalls
|