MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG); PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348); Implant Pain (4561)

Event Date 06/17/2020

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 for the patient's left distal femur.Reason for revision is noted as pain.Also noted: "custom cement over for the mig grower in situ and revision tibial component.".

Event Description

A patient specific implant prescription form was received for the patient's left distal femur.Reason for revision is noted as pain.Also noted: "custom cement over for the mig grower in situ and revision tibial component.".

Manufacturer Narrative

Reported event: an event regarding malposition involving a mig distal femur, tibial stem 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 left mig distal femoral replacement which was inserted on (b)(6) 2014.Clinical reported that the patient has pain.The x-rays provided shows that both femoral and tibial stems are well fixed but the tibial stem is misaligned inside the canal and the knee joint has excessive extension, which might cause the pain in the knee joint.Therefore, the radiographic review can confirm the reason for revision.Device history review: review of the product history records indicate 1 devices was manufactured and accepted into final stock on 19 jun 2014 with no reported discrepancies.Complaint history review: there have been no other events.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: DISTAL FEMUR MINIMALLY INVASIVE GROWER (MIG)
• 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: 10272092
• MDR Text Key: 198754305
• Report Number: 3004105610-2020-00119
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 18731
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR