STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5515-F-502 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Muscular Rigidity (1968); Injury (2348)
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Event Date 06/08/2020 |
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.
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Event Description
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This pi is for the revision of the patient's right knee on (b)(6) 2020.As reported: "doctor stated 'diagnosis is arthrofibrosis.' got lost to followup for 4 years, and developed flexion contracture.Patient washed out (b)(6) 2014, and had poly insert exchanged.Right side.Nothing was loose or broken.Grahm stain was negative [for infection].This will be all information due to hospital policies." spoke to rep.The patient's ps knee construct was revised to a ts knee on (b)(6) 2020 due to the reported flexion contracture.
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Search Alerts/Recalls
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