STRYKER ORTHOPAEDICS-MAHWAH MRH TIBIAL B/PLT KEEL SML 1; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 6481-3-110 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Date 03/04/2021 |
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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A patient specific solutions request was received for the patient's right distal femur with notes: "underwent constrained tka with stryker components and after initial postop period of doing well has had persistent osteolysis, pain and decreasing function.Allergy testing revealed nickel allergy and multiple blood and aspirations of the joint have been negative for infection." a nickel free distal free femur implant is being requested with a planned date of surgery (b)(6) 2021.
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Search Alerts/Recalls
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