STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
|
Back to Search Results |
|
Catalog Number UNK_JR |
Device Problem
Mechanical Problem (1384)
|
Patient Problems
Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
|
Event Date 01/18/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
An event regarding range of motion (rom) involving an unknown knee was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
|
|
Event Description
|
It was reported through the stryker facebook page, "wow, finally some one that sounds truthful.I am almost 5 weeks post op and the pain and re swelling is unbearable.Tightness and heaviness.Never seems to go away.Especially painful at night." additional fb comment, "i am 6 weeks post op today and still feel horrible.My foot is so swollen i still can't wear a shoe.Cant advance in p/t because i swell up right after, still need a walker.Think i have to cancel a bucket list trip in (b)(6) after being assured by many that i would be great by then having surgery on (b)(6).I am very sorry that i did this.".
|
|
Search Alerts/Recalls
|
|
|