STRYKER ORTHOPAEDICS-MAHWAH MRS FEM STEM W/O BODY 17X203MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 6485-3-617 |
Device Problem
Migration (4003)
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Patient Problem
Ambulation Difficulties (2544)
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Event Date 10/14/2022 |
Event Type
Injury
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Event Description
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It was reported through the submission of a revision usage sheet that the patient's right knee was revised.A gmrs/ mrh construct was implanted.Update 17/october/2022: spoke to rep.Reason for revision was migration of the stem and suspected loosening of the distal femoral component (loosening confirmed intra-operatively).The stem and distal femur were revised to the same catalog numbers.Other internal components (inserts, bushes, axle, etc) were also revised.Rep confirmed there are no allegations against any of the other revised components.
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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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