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

Catalog Number UNK_STM

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348); Cancer (3262)

Event Date 09/19/2019

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

The sales rep reported that "this is a new complaint regards pin (b)(4): you have all the information.Regards the patient in the custom case filed last year for this case.1st surgery done (b)(6) 2018.I received a call yesterday end of afternoon from the head nurse to inform me that the patient is infected.They tried to do several washings and at first the surgeon wanted to do an amputation.The family refused and now they just asked me if it is possible to sterilize part of this implant for an eventual next surgery.For sure i answered that it is not possible for the femoral part where there is a magnet.The customer wants to know if: is it possible to keep the tibial component and sterilize it? is it possible to keep the femoral stem and sterilize it? do we accept to do a new custom in this conditions and is it possible legally?.

Manufacturer Narrative

Reported event: an event regarding septic loosening involving a jts distal femur was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no items were returned.Clinician review:not performed as no medical records were provided.Product history review: review of the product history records indicate (b)(4) device was manufactured and accepted into final stock on 10 dec 18 with no reported discrepancies.Complaint history review: based on the device identification the complaint databases were reviewed from 20sep2016 to present for similar reported events regarding infection of a distal femur, jts.There have been 6 other events.There have been no other events for the sterile lot referenced conclusions: an event regarding septic loosening involving a jts distal femur was reported.The exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and 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.Catalog numbers and lot codes of other devices listed in this report: smbpr00 (b14878) smiles knee bumper pad smbpr00 (b18830) smiles knee bumper pad smbsh00 (b18405) smiles knee bushes smcap01 (b20746) axle cap smtbc00g (b21520) passive grower tibial bearing it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

The sales rep reported that "this is a new complaint regards pin 21618: you have all the information regards the patient in the custom case filed last year for this case.1st surgery done (b)(6) 2018.I received a call yesterday end of afternoon from the head nurse to inform me that the patient is infected.They tried to do several washings and at first the surgeon wanted to do an amputation.The family refused and now they just asked me if it is possible to sterilize part of this implant for an eventual next surgery.For sure i answered that it is not possible for the femoral part where there is a magnet.The customer wants to know if: ¿is it possible to keep the tibial component and sterilize it? ¿is it possible to keep the femoral stem and sterilize it? ¿do we accept to do a new custom in this conditions and is it possible legally?.

• 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; GB WD6 3SJ
• MDR Report Key: 9174354
• MDR Text Key: 161802310
• Report Number: 3004105610-2019-00112
• 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,other
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21618
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 10 YR