Model Number 1035-53-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Discomfort (2330)
|
Event Date 12/14/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.T complaint # (b)(4).
|
|
Event Description
|
It was reported that the surgeon explained the patient was feeling some discomfort in their right hip.She believed it to be due to the wearing of the bipolar component on the patient's native acetabulum.The surgeon believed it would be best to convert this patient's bipolar into a total hip.The bipolar component and 28mm head were removed, allowing ample room for the surgeon to ream out the acetabulum.After reaming the acetabulum, a 54mm gription multi hole cup was implanted.A trial reduction was performed after implanting a 54x36mm +4 10 degree liner.The patient had lost some length, so a +15.5 was trialed and found to be satisfactory.The real head was opened and implanted.The hip was reduced and found to be stable.The closing process began.Doi: (b)(6) 2019, dor: (b)(6) 2020, right hip.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.Device history lot : per wi-3430, review of the device history record is unlikely to add value to the complaint investigation regarding an allegation of pain/discomfort.
|
|
Search Alerts/Recalls
|
|