MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE MIDSHAFT FEMUR JTS; LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 04/17/2018

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.Device not returned.

Event Description

It has been reported that the upper part of the patients prosthesis has collapsed.

• Brand Name: MIDSHAFT FEMUR JTS
• 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: margaret foley ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 7649424
• MDR Text Key: 112702252
• Report Number: 3004105610-2018-00050
• 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: Physician
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2007
• Device Catalogue Number: UNK_STM
• Device Lot Number: PN 12560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2007
• 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
• Treatment: MIDSHAFT FEMUR JTS EXTENSION SHAFT PIN (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR