STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ4 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5512-F-402 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Injury (2348)
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Event Date 03/20/2019 |
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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It was reported that the patient's right knee was revised.As reported by rep: "this is a revision to a revision done on (b)(6) 2016 [(b)(6) 2016 revision was of competitor devices].The current revision was due to a suspected loose femoral component, as stated by surgeon".A size 4 ts femoral component with stem and augments, and a ts insert were revised to another size 3 ts femoral component with stem and stem extender, augments, and another ts insert.Rep provided implant sheets from current and previous revision, pre-revision x-rays, and reported that no further information will be available.
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Manufacturer Narrative
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An event regarding loosening involving a triathlon femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the medical records were deemed insufficient for medical review.The clinician has stated - "need operative reports, office/clinical reports, serial x-rays, etc".Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that revision surgery took place due to loosening of the femoral components.The available medical records were provided to the consulting clinician who deemed it insufficient for a medical review.The event could not be confirmed with the information provided.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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Event Description
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It was reported that the patient's right knee was revised.As reported by rep: "this is a revision to a revision done on (b)(6) 2016 [(b)(6) 2016 revision was of competitor devices].The current revision was due to a suspected loose femoral component, as stated by surgeon".A size 4 ts femoral component with stem and augments, and a ts insert were revised to another size 3 ts femoral component with stem and stem extender, augments, and another ts insert.Rep provided implant sheets from current and previous revision, pre-revision x-rays, and reported that no further information will be available.
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Search Alerts/Recalls
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