MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD METS MODULAR DISTAL FEMUR REPLACEMENT IMPLANT; LIMB SALVAGE SYSTEM

Model Number MSFSEXT/120AG

Device Problems Incorrect Device Or Component Shipped (2962); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

It was reported by the surgeon that the component that was delivered was incorrect.The order was placed for qty of 1 of msfsext/120ag and the delivery contained a quantity of 1 of msfshft/120ag.

Manufacturer Narrative

A review of the process confirmed that the incorrect item was ordered at customer svc.This was due to human error entering the item onto the order system.This has been highlighted to the customer svc team.Requests are being made for add'l info and a supplemental report will be provided if this info is received.

Manufacturer Narrative

During the investigation it was determined that the order entered on the syspro system was incorrect.Syspro is a software for processing an order, the picking and packing is done from these entries.In this particular case, all procedures were followed and the failure to enter the correct order number was down to human error.It cannot be determined if the incorrect order was placed by the hospital, or was entered incorrectly at stanmore implants worldwide.The relevant personnel were notified of the complaint and advised of the importance of entering the correct order number.The complaint is being closed, and is being tracked and trended.

Event Description

It was reported by the surgeon that the component that was delivered was incorrect.The order was placed for qty of 1 of msfsext/120ag (extension shaft) and the delivery contained a quantity of 1 of msfshft/120ag (principal shaft.(b)(4).

• Brand Name: METS MODULAR DISTAL FEMUR REPLACEMENT IMPLANT
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE LTD; 210 centennial avenue; centennial park; elstree, WD6 3 SJ; UK WD6 3SJ
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 4373409
• MDR Text Key: 5234302
• Report Number: 3004105610-2014-00157
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSFSEXT/120AG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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