STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 6MM TIBIA OFFSET; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
|
Back to Search Results |
|
Catalog Number UNK_JR |
Device Problem
Osseointegration Problem (3003)
|
Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
|
Event Date 08/27/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
An event regarding loosening involving tibial offset was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: deemed insufficient for medical review [.] ¿ cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not returned.
|
|
Event Description
|
It was reported that the patient's right knee was revised due to progressive radiolucency around the tibial and femoral stems.A knee construct with tibial baseplate and stem, femoral component and stem, and a cs insert were revised to a ts construct.Rep provided a webops report, an excerpt from an operative report, explant pictures and x-rays from (b)(6) 2019 and reported that no further information will be available.
|
|
Search Alerts/Recalls
|
|
|