STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Model Number 6021-2530 |
Device Problem
Corroded (1131)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 06/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that the patient's right hip was revised due to corrosion.The patient's stem, head and liner were revised.Rep confirmed there are no allegations against the revised liner.Rep can provide some device pictures, and confirmed that no further information will be released.
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Manufacturer Narrative
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Reported event: an event regarding corrosion involving accolade stem was reported.The event was confirmed based on photographs provided.Method & results: -device evaluation and results:visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted stem with blackening around the junction of stem and neck.Material analysis, 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 -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: it was reported that the patient's right hip was revised due to corrosion.The event was confirmed based on photographs provided.The reported device was not returned however photographs were provided for review.The photographs shows a recently explanted stem with blackening around the junction of stem and neck.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
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Event Description
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It was reported that the patient's right hip was revised due to corrosion.The patient's stem, head and liner were revised.Rep confirmed there are no allegations against the revised liner.Rep can provide some device pictures, and confirmed that no further information will be released.
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Search Alerts/Recalls
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