Catalog Number UNK_JR |
Device Problem
Osseointegration Problem (3003)
|
Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
|
Event Date 12/29/2009 |
Event Type
Injury
|
Manufacturer Narrative
|
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
|
|
Event Description
|
This pi is for the revision of the patient's left hip in 2009.In reporting a revision of patient's left hip on (b)(6) 2019 ((b)(4)), rep was told that the patient had a revision in 2009 due to aseptic loosening of the trident shell.The shell and liner were revised to competitor devices.Rep reported that no further information will be available.
|
|
Manufacturer Narrative
|
An event regarding loosening involving a unknown shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual, dimensional, functional and material analysis not be performed as the device is not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of the device history records could not be performed as lot information was not provided.Complaint history review: a complaint history review could not be performed as lot code information was unknown. conclusions: it was reported that patient was revised due to loosening.The event could not be confirmed nor the exact cause of the event could be determined because insufficient information was available.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by stryker orthopaedics.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
This pi is for the revision of the patients left hip in 2009.In reporting a revision of patients left hip on (b)(6) 2019 (b)(4)), rep was told that the patient had a revision in 2009 due to aseptic loosening of the trident shell.The shell and liner were revised to competitor devices.Rep reported that no further information will be available.
|
|
Search Alerts/Recalls
|