STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
|
Back to Search Results |
|
Catalog Number 5531G411 |
Device Problem
Mechanical Problem (1384)
|
Patient Problems
Injury (2348); Ambulation Difficulties (2544)
|
Event Date 01/17/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
An event regarding a range of motion issue (flexion contracture) involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.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 available.
|
|
Event Description
|
It was reported that the patient's right knee was revised due to insufficient flexion.The surgeon performed a debridement and poly swap of a 4x11 cs insert.There were no defects of the revised insert observed.Rep reported that x-rays, medical records, and further information are not available.
|
|
Search Alerts/Recalls
|
|
|