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

Catalog Number UNK_STM

Device Problem Material Distortion (2977)

Patient Problems Injury (2348); Cancer (3262)

Event Date 03/26/2018

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

A new prescription form has been received for a revision due to instability.It has been further reported that the hinge element has warped.

• 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: 7439151
• MDR Text Key: 105754229
• Report Number: 3004105610-2018-00029
• 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: Physician
• Type of Report: Initial
• Report Date: 04/18/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_STM
• Device Lot Number: PIN1461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/1989
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR