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

Catalog Number UNK_STM

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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.Device not returned.

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.".

Manufacturer Narrative

Update 01 apr 21: a further discussion was held with the clinician and senior investigator, the following was found: the loosening mentioned was not in relation to any loss of osseointegration, and the disassociation between the femoral stem and tibial component is just a consequence of the axle backing out, therefore 3004105610-2021-00012 for the femoral stem and 3004105610-2021-00036 for the tibial component will be cancelled.

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".Update 01 apr 21: a further discussion was held with the clinician and senior investigator, the following was found: the loosening mentioned was not in relation to any loss of osseointegration, and the disassociation between the femoral stem and tibial component is just a consequence of the axle backing out, therefore 3004105610-2021-00012 for the femoral stem and 3004105610-2021-00036 for the tibial component will be cancelled.

• Brand Name: PROXIMAL TIBIA - FEMORAL COMPONENT
• 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: 11226838
• MDR Text Key: 241236643
• Report Number: 3004105610-2021-00012
• 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: 04/09/2021

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: 01/05/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR