STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5521-B-600 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 10/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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The following devices were also listed in this report: triathlon asym patella a38x11; cat# 5551l381; lot# lct627.Triathlon ps x3 tibial insert; cat# 5532-g-609; lot# mld7p7.Triathlon ps fem component, cemented; cat# 5515-f-501; lot# giona.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
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Event Description
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It was reported through the communication of an attorney that allegedly the patient was revised due to "persistent left knee pain and patient status post left total knee arthroplasty with overhanging tibial component.".
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Search Alerts/Recalls
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