Catalog Number 103540000 |
Device Problem
Connection Problem (2900)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/16/2018 |
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
|
Der states that the bipolar liner would not lock into bipolar shell.Surgical delay- 5 minutes; doe: (b)(6) 2018.
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Der states that the bipolar liner would not lock into bipolar shell.Surgical delay- 5 minutes; doe: (b)(4) 2018.
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # pc-(b)(4).Investigation summary examination of the returned device is not able to confirm the reported problem.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.
|
|
Search Alerts/Recalls
|