MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR JTS - TIBIAL COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_STM

Device Problem Insufficient Information (3190)

Patient Problem Unequal Limb Length (4534)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding a limb length discrepancy involving a jts distal femur, tibial component was reported.The event was confirmed by x ray review.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 jts distal femoral replacement which was inserted on (b)(6) 2015.The surgeon reported maximum extension of the implant and leg length discrepancy.The x-rays provided show that the implant has almost reached to its maximum extension of 50 mm, thus the implant has fulfilled its intended use and no further investigation is required.In addition, the affected leg is shorter than the opposite leg due to shortening of the tibial bone.Therefore, the radiographic review can confirm the clinical report and reason for revision.Device history review: review of the product history records indicate (b)(4) device was manufactured and accepted into final stock on 02 october 2015 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, 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.Device not returned.

Event Description

A patient specific implant prescription form was received for the patient's right distal femur (jts).Noted on the form: "the patient currently has a limb length discrepancy and is still growing.Jts df has reached terminal extension." update : the clinician reviewed the imaging provided and found the following : "in addition, the affected leg is shorter than the opposite leg due to shortening of the tibial bone".

• Brand Name: DISTAL FEMUR JTS - 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
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 10920985
• MDR Text Key: 218738539
• Report Number: 3004105610-2020-00190
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 19683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2020
• Initial Date FDA Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 58