MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE DISTAL FEMUR LIMB SALVAGE SYSTEM

Catalog Number UNK_STM

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Injury (2348)

Event Date 03/11/2019

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. Device not available.

Event Description

A patient specific implant prescription form was received for patient's impending revision with diagnosis "re-bushings dfr from 1989" additional notes indicate: re-bushings in 2012, bushes ref: stbsh01-02, bme: 17262, circlip: ref smcic01.

• Brand Name: DISTAL FEMUR
• 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: 8490785
• MDR Text Key: 141165379
• Report Number: 3004105610-2019-00043
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K140898
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/1995
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN 3541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/1995
• 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: 04/08/2019 Patient Sequence Number: 1