STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_OSTEONICS 'ENCAPSULATED' (ONE-PIECE) SHELL AND POLY; LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number UNK_JR |
Device Problems
Degraded (1153); Unstable (1667)
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Patient Problems
Pain (1994); Joint Laxity (4526)
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Event Date 05/18/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient's left hip was revised.As reported: "pt presented with complaint of hip pain/instability.Imaging showed signs of uneven poly wear leading to instability.Pt.Received a tha in 1985, osteonics components.Dr.Opted to revise the shell, leaving the monobloc cemented-stem and 26mm head in-situ.He used our uhr bipolar head to articulate with a 44mm id poly-insert from competitor.No complaints against the components themselves, no further info available." spoke to rep.The revised device was an 'encapsulated' acetabular component, a metal shell with poly inside as a single device, which was cemented into the patient's acetabulum.
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Manufacturer Narrative
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Reported event: an event regarding instability and wear involving an unknown shell/liner 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 was revised due to instability and poly wear.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.
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Search Alerts/Recalls
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