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

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Date 06/23/2014

Event Type  malfunction  

Event Description

It was reported by the surgeon that the jts drive unit is not functioning as it should and it not lengthening the prosthesis.

Manufacturer Narrative

The drive unit has not been returned for evaluation, so it is not possible to identify the root cause with the current available information.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 avenue; centennial park; elstree WD63S-J ; UK WD63SJ ; 082386500
• MDR Report Key: 4373100
• MDR Text Key: 17222773
• Report Number: 3004105610-2014-00181
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K092138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2014

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?: Yes
• Date Manufacturer Received: 06/23/2014
• 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