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 Unintended Movement (3026)

Patient Problems Ambulation Difficulties (2544); Unequal Limb Length (4534)

Event Date 04/25/2022

Event Type  Injury  

Manufacturer Narrative

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

A patient specific implant prescription form was received for the patient's left distal femur jts.Noted on the form: "leg length discrepancy, terminally extended jts in place.Will leave femoral stem in place.Tibia will require revision." 03may22 update "the proximal tibia is not growing and i think that it has subsided.If it is well fixed, then will leave in situ.If it is not well fixed will revise.Happy to go to an adult style if it will marry to the jts".

Event Description

A patient specific implant prescription form was received for the patient's left distal femur jts.Noted on the form: "leg length discrepancy, terminally extended jts in place.Will leave femoral stem in place.Tibia will require revision." 03may22 update "the proximal tibia is not growing and i think that it has subsided.If it is well fixed, then will leave in situ.If it is not well fixed will revise.Happy to go to an adult style if it will marry to the jts".

Manufacturer Narrative

Reported event: an event regarding a jts, distal femoral replacement, tibial component was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the subject device was not returned and no photographs were provided for review.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) 2017.The surgeon reported leg length discrepancy and proximal tibia not growing.The x-ray image provided shows that the implant has been extended by 50mm which reached its maximum capacity of 50mm.The length of the affected leg is about 706cm which is similar to the opposite leg.However, the length of the affected tibia is 294cm which is shorter than the opposite tibia (308cm).In addition, the affected tibial epiphyseal area has deformed which affected the tibial grow.Therefore, the radiographic review can confirm the clinical report and reason for revision.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 relevant events for the lot referenced.Conclusion: the clinical review confirmed the reason for revision as limb length discrepancy and states: "the affected tibial epiphyseal area has deformed which affected the tibial grow".However the reported subsidence event can not be confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and progress notes 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 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: 14468748
• MDR Text Key: 292350850
• Report Number: 3004105610-2022-00084
• 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,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2017
• 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: 12 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Race: White