MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD. JTS NON-INVASIVE EXTENDIBLE DISTAL FEMUR REPLA; DISTAL FEMUR IMPLANT

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/22/2014

Event Type  malfunction  

Event Description

It was reported by a company representative that the drive unit was supplied with a (b)(4) power adapter and not the correct adapter for use in france.

Manufacturer Narrative

A review of the manufacturing details confirmed that the complaint was confirmed.This had not been noted due to human error as part of the manufacturing process.No adverse effects on the patient as the company representative sourced the correct power cord prior to the procedure starting.Requests are being made for additional information and a supplemental report will be provided if this information is received.

• Brand Name: JTS NON-INVASIVE EXTENDIBLE DISTAL FEMUR REPLA
• Type of Device: DISTAL FEMUR IMPLANT
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE LTD.; elstree, hertfordshire ; UK
• Manufacturer Contact: sian rogers ; 210 centennial ave., centennial park; elstree WD63S-J ; UK WD63SJ ; 082386500
• MDR Report Key: 4373067
• MDR Text Key: 18732200
• Report Number: 3004105610-2014-00177
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2014
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other