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

Catalog Number UNK_STM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 11/02/2020

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

A patient-specific implant prescription form was received for the patient's left distal tibia.Noted on the form: "the patient has a cement spacer now (after the implant removal.Reason: infection.".

Event Description

A patient-specific implant prescription form was received for the patient's left distal tibia.Noted on the form: "the patient has a cement spacer now (after the implant removal.Reason: infection.".

Manufacturer Narrative

Reported event: an event regarding infection involving a mig, distal tibial replacement was reported.The event was not confirmed.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 previous implant was for mig distal tibial replacement which was inserted in 2019.The surgeon reported an infection of the implant.The ct image provided shows that the implant has been removed and the cement spacer is in situ.The remaining bone is in good condition, there is no obvious osteolysis and bone lesion that might indicate bone infection.The image of the bone shows some blurriness but no difference from the opposite tibia.Therefore, the radiographic review cannot confirm infection which has to rely on clinical evidence.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 18 jun 2019 with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Sterile lot: uk34s12292470-1-1 there have been no other events for the sterile 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, x-rays 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 TIBIA 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: 10897511
• MDR Text Key: 218158753
• Report Number: 3004105610-2020-00183
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR