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

Catalog Number UNK_STM

Device Problems Mechanical Problem (1384); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problems Injury (2348); Cancer (3262)

Event Date 01/15/2020

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 prescription form was submitted for a patient's left proximal tibia.Diagnosis is "failure of device" notes state revision of jammed mig proximal tibia.".

Manufacturer Narrative

Reported event: an event regarding spontaneous extension and seizing involving a minimally invasive grower, proximal tibia, extension mechanism was reported.The spontaneous extension of the device was confirmed via the x ray review, however, the jamming / seizing event was not confirmed.Methods and results: device evaluation and results: not performed as device was not returned.Clinicians review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a mig proximal tibia replacement which was inserted on the (b)(6) 2011.The surgeon reported the implant is still jammed after several times of collar insertion.In addition, the design engineer has verbally reported that the implant has spontaneously extended and then jammed again.The x ray provided showed that the implant has been extended with a collar in situ, and there is an additional extension that can be observed between the tibia shaft and the collar.However, radiographic review cannot assess jamming of the implant.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 01 feb 2011 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 01-jan-2017 to present for similar reported events regarding mig, proximal tibia, extension mechanism, non functional / seizing.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, 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

A patient prescription form was submitted for a patient's left proximal tibia.Diagnosis is "failure of device" notes state revision of jammed mig proximal tibia.".

Event Description

A patient prescription form was submitted for a patient's left proximal tibia.Diagnosis is "failure of device" notes state revision of jammed mig proximal tibia." update 23sep2020 - device was returned.

Manufacturer Narrative

Reported event: an event regarding spontaneous extension and seizing involving a minimally invasive grower, proximal tibia was reported.The spontaneous extension of the device was confirmed via the x ray review, however, the jamming / seizing event was not confirmed.Methods and results: device evaluation and results: visual inspection of the tibial component indicated several scratches on the device surface.Moreover, it is possible to notice the fractured bit of the extraction screw in the locking screw port.The tibial component was returned cut distally.Clinicians review: a review of the provided x-rays by a clinical consultant indicated: the implant in situ was for a mig proximal tibia replacement which was inserted on the (b)(6) 2011.The surgeon reported the implant is still jammed after several times of collar insertion.In addition, the design engineer has verbally reported that the implant has spontaneously extended and then jammed again.The x ray provided showed that the implant has been extended with a collar in situ, and there is an additional extension that can be observed between the tibia shaft and the collar.However, radiographic review cannot assess jamming of the implant.Device history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 01feb2011 with no reported discrepancies.Complaint history review: there have been no other events.Conclusion: an event regarding spontaneous extension and seizing involving a minimally invasive grower, proximal tibia was reported.The spontaneous extension of the device was confirmed via the x ray review, however, the jamming / seizing event was not confirmed.A meeting was held with a design engineer to discuss the recent the failure of the device with the sales rep / surgeon.A summary of the meeting is stated "the sales rep and surgeon reported the following to the design team in (b)(6) 2020: the patient¿s implant first spontaneously extended, and then jammed.The surgeon then attempted to retract the implant; this was unsuccessful." on (b)(6) 2020, the following was reported "the surgeon was pleased with the outcome [of the revision] and mentioned the operation duration was quick." the exact cause of the event could not be determined since the device was returned cut and no functional test could be performed.If further information becomes available, this investigation will be re-opened.

• Brand Name: PROXIMAL TIBIA MINIMALLY INVASIVE GROWER (MIG) - TIBIAL 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: 9680302
• MDR Text Key: 178116112
• Report Number: 3004105610-2020-00024
• 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,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• 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 15640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR