STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL MULTI; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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Catalog Number 508-11-62G |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Bone Fracture(s) (1870); Injury (2348); Hip Fracture (2349); Inadequate Osseointegration (2646)
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Event Date 08/09/2019 |
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 other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
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Event Description
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Revision of right hip acetabulum due to implant loosening with periprosthetic acetabular fracture.Update 09/august/2019 wg: an acetabular shell and 3 screws were reported revised.
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Event Description
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Revision of right hip acetabulum due to implant loosening with periprosthetic acetabular fracture.Update 09/august/2019 wg: an acetabular shell and 3 screws were reported revised.
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Manufacturer Narrative
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An event regarding loosening & periprosthetic fracture involving a trident shell was reported.The event was confirmed by medial review of the provided records.Method & results: device evaluation and results: visual inspection: the reported device was returned for analysis.The shell was returned with the liner inside it and 3 screws protruding from it.There was slight damage identified on the shell surface.Overall there was nothing else remarkable to report.Dimensional & functional inspection: not performed as these aspects are not in question.Material analysis not performed as this event does not relate to material integrity.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray shows dislocated hip with loose acetabular component with medial acetabular wall fracture and prostusio on the right with broken screws; need additional information; primary and revision operative reports (only admission notes provided), clinical and past medical history, post op x- rays and examination of explanted components.Device history review: all 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: x-ray shows dislocated hip with loose acetabular component with medial acetabular wall fracture and prostusio on the right with broken screws; the exact cause of the event could not be determined because insufficient information was provided.Additional information including additional information; primary and revision operative reports (only admission notes provided), clinical and past medical history, post op x- rays and examination of explanted components are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
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Search Alerts/Recalls
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