STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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Catalog Number 5532-G-611 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Scar Tissue (2060); Injury (2348)
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Event Date 10/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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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.The following devices were also listed in this report: triathlon asymmetric x3 patella; cat#5551-g-381; lot#230j; triathlon prim tib baseplate - cemented; cat#5520-b-600; lot#toelb; triathlon ps fem component, cemented; cat#5515-f-501; lot#tdrsd; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A 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.Device not available.
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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 "arthrofibrosis, left knee, status post total knee replacement.".
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Search Alerts/Recalls
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