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

Catalog Number UNK_STM

Device Problems Osseointegration Problem (3003); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Inadequate Osseointegration (2646); Cancer (3262)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

The reported device is similar to a device approved for compassionate use in the united states.Review of the product history records indicate device was manufactured and accepted into final stock with no reported discrepancies.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.Not returned to the manufacturer.

Event Description

A patient specific prescription form was received for the patient's proximal tibia with the following notes, "femoral shaft with stress shielding, distal femur/long stem.".

Manufacturer Narrative

Reported event: an event regarding loosening (bone resorption) involving a mig proximal tibia was reported.The event was confirmed by medical review.Method and results: product evaluation and results: not performed as no items were returned.Clinician review: the implant in situ was for a mig proximal tibial replacement which was inserted on (b)(6) 2011.The surgeon reported stress shielding of the femoral bone.The x-rays provided showed that the femoral bone has undergone remodelling and resorption in which part of the cortical bone become thinner and bone density has reduced.These changes could be due to stress shielding effect from the stem.In addition, a minor fracture has been noted on the lateral cortex near the tip of the stem (see arrow), which may be due to stress shielding caused weak bone.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on 24nov2011 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed for similar reported events.There has been 1 other event.Conclusions: an event regarding bone resorption involving a mig proximal tibia was reported.The event was confirmed by medical review.The exact cause of the event could not be determined because further information such as the primary operative report as well as patient history and follow up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and/or insufficient information was received by siw.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be re-opened.

Event Description

A patient specific prescription form was received for the patient's proximal tibia with the following notes, "femoral shaft with stress shielding, distal femur/long stem." update 23apr2020 - during the clinician review, a peri-prosthetic fracture was also identified.This fracture is linked to the reported stress shielding, as reported by the clinician "the femoral bone has undergone remodelling and resorption in which part of the cortical bone become thinner and bone density has reduced.[.] a minor fracture has been noted [.], which may be due to stress shielding caused weak bone.".

• Brand Name: PROXIMAL 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; GB WD6 3SJ
• MDR Report Key: 9962933
• MDR Text Key: 188058179
• Report Number: 3004105610-2020-00084
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 16729
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR