MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA - AXLE; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

As reported: "[patient] has some problems with the femoral side and i would like to revise this.I am hoping to leave the tibia alone.Can i have a new femur available, new bushings, a new rotating piece for the tibia (with poly) and a new axle and circlip." update 20 feb 21: the x ray review stated the following " the x-ray images provided show that the axle has backed out on lateral side indicating that the knee hinge has loosened, and the femoral component has disengaged with the tibial component".

Event Description

As reported: "[patient] has some problems with the femoral side and i would like to revise this.I am hoping to leave the tibia alone.Can i have a new femur available, new bushings, a new rotating piece for the tibia (with poly) and a new axle and circlip." update 20 feb 21: the x ray review stated the following " [.] the x-ray images provided show that the axle has backed out on lateral side indicating that the knee hinge has loosened, and the femoral component has disengaged with the tibial component".

Manufacturer Narrative

Reported event: an event regarding backing out involving a patient specific, proximal tibia, axle was reported.The event was confirmed by x ray review.Method & results: 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 a proximal tibial replacement which was inserted on (b)(6) 2003.The surgeon reported some problems on femoral component.The x-ray images provided show that the axle has backed out on lateral side indicating that the knee hinge was loosened, and the femoral component has disengaged with the tibial component.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate the device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the 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 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.

• Brand Name: PROXIMAL TIBIA - AXLE
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• MDR Report Key: 11480634
• MDR Text Key: 239663194
• Report Number: 3004105610-2021-00037
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2003
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 9725
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR