Catalog Number 5530-G-309 |
Device Problems
Crack (1135); Noise, Audible (3273)
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Patient Problem
No Information (3190)
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Event Date 02/02/2009 |
Event Type
Injury
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Event Description
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Patient called and stated prior to her bilateral knee surgeries, she could hear her knees "cracking." patient is now saying that she hears her implants making a "cracking" noise.Patient also stated in (b)(6) 2010 "surgeon put in patella's".Patient has tendinitis.
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Manufacturer Narrative
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Catalogue number unknown at this time.Device description reported as unknown right knee.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device remains implanted.
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Manufacturer Narrative
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An event regarding instability involving a triathlon cr x3 tibial insert was reported.The event was confirmed.A review of the provided medical records and/or x-rays by a clinical consultant concluded: ¿on (b)(6) 2010 resurfacing of bilateral patellae and change of the tibial insert on the right was performed for a diagnosis of right knee instability.[.]there is no evidence that this patient¿s chronic bilateral knee pain is due to factors of faulty prosthetic design, manufacturing, or materials.Her last documented diagnosis of (b)(6) 2013 was bilateral patellar tendinitis and x-rays on that date demonstrated no prosthetic component related abnormalities.¿ device history review: indicated all devices accepted into final stock met specifications.Complaint history review: there have been no other events for the lot referenced.The exact cause of the reported instability could not be determined.A review of the provided records by a clinical consultant indicated there is no evidence the event is device related.The reported event noted patient hears ¿cracking¿ noise but medical records provided to clinical consultant only noted pain leading to revision of insert for instability was experienced by the patient.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.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, this investigation will be reopened.
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Event Description
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Patient called and stated prior to her bilateral knee surgeries she could hear her knees "cracking" patient is now saying that she hears her implants making a "cracking" noise.Patient also stated in (b)(6) 2010 "surgeon put in patella's".Patient has tendinitis.
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Search Alerts/Recalls
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