STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_STRYKER KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 03/22/2023 |
Event Type
Injury
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Event Description
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Patient stated he had a knee implant on (b)(6) 2020 and is experiencing loosening and pain.Did not state if loosening was confirmed by his doctor.Patient would like to know if products are subject to recall.
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Manufacturer Narrative
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Reported event: an event regarding loosening 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 was not returned.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: it was reported that the patient is experiencing pain and loosening post-implantation.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.It was further reported that the patient is inquiring whether their implants are part of a recall.Device-identifying information such as catalog number and lot code are required to determine if the devices are subject to a recall.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.
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Search Alerts/Recalls
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