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 Failure to Advance (2524); Activation Failure (3270)

Patient Problems Unequal Limb Length (4534); Insufficient Information (4580)

Event Date 03/22/2021

Event Type  malfunction  

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: "we received a call from dr regarding the implant not reaching the full expansion of 52mm as per the design proposal.This incident occurred during the 2nd expansion surgery." operative side: right.

Manufacturer Narrative

Reported event: an event regarding seizing involving a mig, distal femoral replacement, extension mechanism 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 mig distal femoral replacement which was inserted in 2019.The surgeon reported that the implant could not reach the full expansion of 52mm.The x-ray images provided show that from 8th march 2021, 9th march 2021 and 10th march 2021, the extension gaps were measured as 26.5mm, 29.6mm and 26.6mm respectively, which indicated that the implant hasn¿t been extended.The 4mm difference between 8th march and 9th march measurement could be due to the accuracy of the measurement and orientation of the x-rays.Therefore, the radiographic review can confirm that the implant hasn¿t been extended and further investigation is required.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: on the 22nd of march 2021 the sales rep reported that mig, distal femoral replacement pin 21909 was not reaching the full expansion of 52mm.On 7th of april the sales rep confirmed the patient has undergone a total of five lengthening procedures.The last procedure was on 9th of march 2021 whereby minimal lengthening was achieved and no further extension was possible.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

As reported: "we received a call from dr.Regarding the implant not reaching the full expansion of 52mm as per the design proposal.This incident occurred during the 2nd expansion surgery." operative side: right.Update 29 jul 2021: sales rep reported that the patient underwent five extensions in total.The last extension was on 09 march 2021 whereby minimal extension was achieved (4mm).

• 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: 11668796
• MDR Text Key: 245606657
• Report Number: 3004105610-2021-00062
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21909
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR