STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN GMRS DISTAL FEMUR; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number UNK_LIM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Bone Fracture(s) (1870); Inadequate Osseointegration (2646); Cancer (3262)
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Event Date 02/14/2022 |
Event Type
Injury
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Event Description
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As reported: "remove existing gmrs distal femur replacement and replace with custom distal femur replacement with side plate, ha on plate, cross screws plate to stem to mate with his existing all poly tibia (8 mm extra-large).There was a failure of the implant twice.Need for extra fixation.Right side.There is no planned date of revision.Update - 23-february-2022: from "brief medical history" section of intake form: "metastatic melanoma with pathological fracture, good disease control immunotherapy now with second episode of aseptic loosening of the stem.".
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Manufacturer Narrative
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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.Device not returned to the manufacturer.
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Search Alerts/Recalls
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