STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/48; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Model Number 1236-2-848 |
Device Problem
Fracture (1260)
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Patient Problem
Pain (1994)
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Event Date 10/13/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient's left hip was revised due to pain.Intra-operatively, it was discovered that the adm/ mdm poly liner was broken in half, and the surgeon reported that the liner was worn where the collar of the metal femoral head was articulating with the poly.A metal mdm liner, poly adm/ mdm insert, and metal femoral head were revised.Rep confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Manufacturer Narrative
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An event regarding crack/fracture involving a adm liner was reported.The event of crack/fracture was confirmed by photographs provided.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: photograph provided showed a recently explanted liner which had fractured into 2 pieces of roughly the same size, the photograph seemed to show damage to the rim of the liner but this could not be confirmed from the photograph provided.-clinician review: a review of the provided medical information by a clinical consultant indicated: confirmation: the event cannot be confirmed without additional medical records and information.Root cause: a root cause cannot be ascertained.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as 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.
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Event Description
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It was reported that the patient's left hip was revised due to pain.Intra-operatively, it was discovered that the adm/ mdm poly liner was broken in half, and the surgeon reported that the liner was worn where the collar of the metal femoral head was articulating with the poly.A metal mdm liner, poly adm/ mdm insert, and metal femoral head were revised.Rep confirmed that no further information will be released by the hospital or surgeon.
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Search Alerts/Recalls
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