STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Unequal Limb Length (4534); Swelling/ Edema (4577)
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Event Date 01/11/2024 |
Event Type
Injury
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Event Description
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It was reported through the stryker facebook page, "had both knees done on (b)(6) 2015.After 8 years i have constant pain and extreme swelling in both knees.Walking is worse now than before.I cannot kneel, cannot get out of a bathtub, only showers for 8 years.I have had 15 falls because the of my knees.The last 2 falls i hit my head.My balance is off and 1 leg is shorter than the other.I have had physical therapy multiple times over the years and it has not helped.Tests show no damage to the appliances but i believe they are too large for my bone structure.I can not do many of the things i could do before tkr." this pi addresses the patient's right knee.
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Manufacturer Narrative
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Reported event: an event regarding limb length discrepancy involving an unknown knee implant was reported.This event was not confirmed.Method & results: device evaluation and results: not performed as product remains implanted.Clinician review: no medical records were received for review with a clinical consultant.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.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 primary 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 to the manufacturer.
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Search Alerts/Recalls
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