MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE JTS PROXIMAL FEMUR (REVISION OF PROXIMAL COMPONENTS) LIMB SALVAGE SYSTEM

Model Number PIN 21882

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); Cancer (3262)

Event Date 04/03/2019

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.

Event Description

At approximately 15:10, on (b)(6) 2019, it was reported by (b)(6) by a phone call to the siw design office, that the surgeon mr (b)(6) was having difficulty inserting the jts revision prosthesis (pin21882). Mr (b)(6) requested the attendance of a design engineer in surgery to troubleshoot why the device was not fitting as intended. (b)(6) went to theatres in (b)(6) as requested and (b)(6) entered theatre 7. The device was confirmed to not fit as intended. The surgeon reinserted the original proximal component and scribed a line on the end of the shaft to annotate the femoral neck angle. He removed this component and inserted the revision component and scribed the neck angle. The discrepancy between the two scribed lines was approximately 90 degrees. On discussion, the surgeon decided to leave the distal femoral component of the jts in situ as the patient still had a leg length discrepancy. On further discussion, the surgeon decided to retain the original proximal component as a spacer scaffold onto which a mets trochanter was cemented allowing the surgeon to close the patient with a view to revising at a later date. The pin numbers being revised were bme(pin)12560 and bme(pin)13138. There was a surgical delay of 30-60 minutes.

• Brand Name: JTS PROXIMAL FEMUR (REVISION OF PROXIMAL COMPONENTS)
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 8499887
• MDR Text Key: 141477353
• Report Number: 3004105610-2019-00046
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K092138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2019
• Device Model Number: PIN 21882
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 21882
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/10/2019 Patient Sequence Number: 1

Treatment

PIN 12560 JTS MIDSHAFT FEMUR; PIN 13138 EXTENSION SHAFT FOR JTS MIDSHAFT FEMUR