MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE PROXIMAL TIBIA MINIMALLY INVASIVE GROWER (MIG) - FEMORAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Cancer (3262)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Device not returned.

Event Description

A patient specific implant prescription form was received with diagnosis "leg length discrepancy right" and notes "proximal component of the tibia should be revised to a new custom component, exchange of the proximal component of the tibia to a new custom component with additional extension capacity.".

Manufacturer Narrative

Based on additional information received from the surgeon and the results of the investigation, it was confirmed that the mig proximal tibial replacement successfully achieved it maximum extension and fulfilled its expected use.The reported limb length discrepancy is an expected outcome of using the device and will be resolved by replacing this device so the patient¿s limb can continue to grow.Therefore, the event has been reassessed as not reportable.

Event Description

A patient specific implant prescription form was received with diagnosis "leg length discrepancy right" and notes "proximal component of the tibia should be revised to a new custom component, exchange of the proximal component of the tibia to a new custom component with additional extension capacity." update from the clinician: the tibial component has nearly reached maximum extension.In addition to this, a limb length discrepancy at the femoral component was identified.

• Brand Name: PROXIMAL TIBIA MINIMALLY INVASIVE GROWER (MIG) - 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; GB WD6 3SJ
• MDR Report Key: 9794037
• MDR Text Key: 183777820
• Report Number: 3004105610-2020-00045
• 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: 06/05/2020

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: 11/30/2013
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 17554
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 29