STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_JOINT REPLACEMENT_PRODUCT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problems
Fracture (1260); Device Dislodged or Dislocated (2923)
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Patient Problems
Injury (2348); Joint Dislocation (2374)
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Event Date 02/14/2019 |
Event Type
Injury
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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.
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Event Description
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Medical review for (revision due to dislocation and fracture of patella, right knee) provided the following additional information: "x-ray confirms patella dislocation and post revision x-ray with new metal back patella shows subluxation".Follow-up has already determined that no additional information will be available.
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Event Description
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Medical review for (revision due to dislocation and fracture of patella, right knee) provided the following additional information: "x-ray confirms patella dislocation and post revision x-ray with new metal back patella shows subluxation".Follow-up has already determined that no additional information will be available.
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Manufacturer Narrative
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An event regarding dislocation involving an unknown patella was reported.The event was confirmed by medical review.Method & results: -device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.-clinician review: the available medical records were provided to the consulting clinician for a review which was rejected stating - "x-ray confirms patella dislocation and post revision x-ray with new metal back patella shows subluxation, need additional information; primary and revision operative reports, clinical and past medical history, and examination of explanted components." -device history review: not performed as the device lot code was not available.-complaint history review: not performed as the device lot code was not available.Conclusions: it was reported that patient had a metal back patella which showed subluxation.The available medical records were provided to the consulting clinician for a review which was rejected stating that the x-ray confirms patella dislocation and post revision x-ray with new metal back patella shows subluxation, need additional information; primary and revision operative reports, clinical and past medical history, and examination of explanted components.The root cause could not be determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
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Search Alerts/Recalls
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