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

Catalog Number UNK_STM

Device Problem Failure to Advance (2524)

Patient Problems Injury (2348); Unequal Limb Length (4534)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

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 specific implant prescription form was received for the patient's right jts distal femur with note: "max extension achieved." update 05aug2020 - as reported by the sales rep, "this revision surgery is not due to expansion achieved but problems with the implant not lengthening as expected.I just found this out today.".

Event Description

A patient specific implant prescription form was received for the patient's right jts distal femur with note: "max extension achieved." update (b)(6) 2020 - as reported by the sales rep, "this revision surgery is not due to expansion achieved but problems with the implant not lengthening as expected.I just found this out today.".

Manufacturer Narrative

Correct data.D6a.Additional manufacturer narrative: an event regarding a distal femur jts achieving maximum extension was initially reported.Subsequently, the sales rep reported that the prescription form was submitted due to seizing.The event was not confirmed.Method & results: product evaluation and results: not performed as no items were received.Clinician review: the implant is situ was for a jts distal femoral replacement which was inserted on (b)(6) 2017.The surgeon reported that the implant has stopped extending.The ct image provided shows that the implant has been extended by 21.6 mm which hasn¿t reached its maximum capacity of 50 mm.Therefore, the radiographic review can confirm the clinical report.However, the reason for the implant not to achieve further extension needs further investigation.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on (b)(6) 2017 with no reported discrepancies.Complaint history review: similar reported events regarding seizing of jts distal femur, not solved with boosting the jts drive unit.There have been 13 other events.Conclusions: an event regarding a distal femur jts achieving maximum extension was initially reported.Subsequently, the sales rep reported that the prescription form was submitted due to seizing.The event was not confirmed.The exact cause of the event could not be determined because further information such as retrieval analysis, further information about prior lengthening procedures, 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.

Manufacturer Narrative

An event regarding a distal femur jts achieving maximum extension was initially reported.Subsequently, the sales rep reported that the prescription form was submitted due to seizing.The event was not confirmed.Method & results: product evaluation and results: visual inspection- the femoral (pin 20967) and tibial (pin 19448) parts of jts distal femur was received, together with 3 tibial plateau plates and femoral stem (never implanted) from pin 22371.Visual inspection of the components received did not identify any damage or non-conformity relevant to the reported event.Functional inspection - a functionality test was performed on pin 20967.The device passed the test.Clinician review: the implant is situ was for a jts distal femoral replacement which was inserted on (b)(6) 2017.The surgeon reported that the implant has stopped extending.The ct image provided shows that the implant has been extended by 21.6 mm which hasn¿t reached its maximum capacity of 50 mm.Therefore, the radiographic review can confirm the clinical report.However, the reason for the implant not to achieve further extension needs further investigation.Product history review: review of the product history records indicate 1 device was manufactured and accepted into final stock on (b)(6) 2017 with no reported discrepancies.Complaint history review: similar reported events regarding seizing of jts distal femur, not solved with boosting the jts drive unit.There have been 13 other events.Conclusions: an event regarding a distal femur jts achieving maximum extension was initially reported.Subsequently, the sales rep reported that the prescription form was submitted due to seizing.The event was not confirmed.The device was returned.Visual inspection of the components received did not identify any damage or non-conformity relevant to the reported event.A functionality test was also performed and the device passed the test.The exact cause of the event could not be determined because further information such as further information about prior lengthening procedures 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 insufficient information was received by siw.If additional information becomes available to indicate further evaluation is warranted, this record will be re-opened.

Event Description

A patient specific implant prescription form was received for the patient's right jts distal femur with note: "max extension achieved.".Update (b)(6) 2020 - as reported by the sales rep, "this revision surgery is not due to expansion achieved but problems with the implant not lengthening as expected.I just found this out today.".Update (b)(6) 2020 - as reported by the sales rep, "we completed this revision surgery last week on nov 5 and all went well.The explant will be returned soon, along with the instruments and unused implants.".

• Brand Name: DISTAL FEMUR JTS
• 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: 10478550
• MDR Text Key: 205168886
• Report Number: 3004105610-2020-00137
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 20967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR