STANMORE IMPLANTS WORLDWIDE TIBIAL COMPONENT ASSEMBLY: ROT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number MKTSC-STD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Swelling/ Edema (4577)
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Event Date 01/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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The reported device is similar to a device approved for compassionate use in the united states.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.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.The following devices were also listed in this report: int coated tib sft&stm: rothng; cat#mptrhiss-55c; lot#b25719; femoral knee component: r std; cat#mptfc-rstd; lot#a30239; prox tib r/hinge plain std; cat#mptrh-stdu; lot#a26594.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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A 2-year henderson classification failure report indicates that patient was revised.As noted: "wound swelling and weeping.Dair and exchange of tibial component to fixed hinge (principal shaft, proximal tibia fixed hinge with bumper, tibial stem, tibial collar, tibial stem, bushes, circlip and axle).".
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Event Description
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A 2-year henderson classification failure report indicates that patient was revised.As noted: "wound swelling and weeping.Dair and exchange of tibial component to fixed hinge (principal shaft, proximal tibia fixed hinge with bumper, tibial stem, tibial collar, tibial stem, bushes, circlip and axle).".
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Manufacturer Narrative
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Reported event: an event regarding infection involving a mets, proximal tibial replacement, tibial component rotating hinge was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: the implant in situ was for mets proximal tibial replacement which was inserted on (b)(6) 2020.The surgeon reported ¿wound swelling and weeping¿.The x-ray images provided show the tibial stem is well fixed inside bone.The stem/bone interface and surrounding bone are in good condition, which may suggest that the surround tissue of swelling and weeping may not yet affect the bone and implant.Clinical biopsy of the bone/implant may be necessary to confirm the infection.Device history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.There have been no other events for the sterile lot referenced.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, pathology reports, progress notes, additional 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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