Model Number 3L92498 |
Device Problem
Osseointegration Problem (3003)
|
Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Inadequate Osseointegration (2646)
|
Event Date 02/23/2021 |
Event Type
Injury
|
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
|
Subject id: 017-03844.Study: dots.Clinical notification received for revision of left total hip to address adverse local tissue reaction date of implantation: (b)(6) 2013.Date of revision: (b)(6) 2021.(left hip).On (b)(6) 2021, the patient underwent a left hip revision to address femoral stem loosening at the bone to implant interface.The surgeon noted the removal of fibrous tissue.The stem, head, and liner were revised.The cup and screw were retained.The patient was revised with depuy products.There were no indicated intra-operative complications.
|
|
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 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 : a device history record (mre) review, was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|