STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER58F; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number 702-04-58F |
Device Problem
Corroded (1131)
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Patient Problem
Pain (1994)
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Event Date 09/19/2023 |
Event Type
Injury
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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 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.H3 other text : not returned to the manufacturer.
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Event Description
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It was reported that the patient's right hip was revised.2 months pos-op, patient complaint of increasing pain.Approximately 1 month prior to revision, increased ion levels were detected.Intra-operatively, corrosion was noted on the mdm metal liner between the metal liner and the shell.
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