STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5530-G-411 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Injury (2348)
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Event Date 07/30/2020 |
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.The following devices were also listed in this report: product long description: triathlon p/a cr beaded #4l; 5517f401.Tritanium bplate triathlon s4; 5536b400; ctd9398.Stryker patellar component; unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not available.
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Event Description
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It was reported that a stage 1 revision was performed on the patient's left knee due to pvns (pigmented villonodular synovitis, the synovium thickens and overgrows into a mass or tumor) and suspected infection after the patient fell.All devices were removed and a spacer placed prior to performing radiation treatment.Rep confirmed that no further information will be released by the hospital or surgeon.
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