STANMORE IMPLANTS WORLDWIDE METS DISTAL FEMUR - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Catalog Number UNK_STM |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Pain (1994); Ambulation Difficulties (2544)
|
Event Date 06/08/2022 |
Event Type
Injury
|
Event Description
|
It has been reported that: "as you can see on the imagery, the circlip has come out of this groove and the axle is coming out of the hinge".The patient had been complaining of pain for some time.No particular event: fall or other.".
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Reported event: an event regarding mets, distal femoral replacement, axle involving disassociation was reported.The event was confirmed by x ray review.Device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for mets distal femoral replacement which was inserted on 01jun2011.The surgeon reported that the circlip and axle have come out.The x-ray images provided show that the circlip has come out of the hinge and the axle has backed out medially.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: a review of the product history records could not be performed as the lot / batch information was not provided.Complaint history review: a complaint history review could not be performed as the lot / batch information was not provided.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, 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.
|
|
Event Description
|
It has been reported that: "as you can see on the imagery, the circlip has come out of this groove and the axle is coming out of the hinge".The patient had been complaining of pain for some time.No particular event: fall or other.".
|
|
Search Alerts/Recalls
|
|
|