MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE LTD JTS NON-INVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT; LIMB SALVAGE SYSTEM

Lot Number BME17092

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

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

Event Date 06/03/2013

Event Type  malfunction  

Event Description

The jts external drive unit is used periodically to lengthen the prosthesis when the patient's limb discrepancy needs to be addressed.On (b)(6) 2012, the patient was implanted with a jts extendible distal femur implant (compassionate use approval dated (b)(6) 2012).During a 16 minute implant lengthening procedure performed on (b)(6) 2013, the external drive unit started flashing an "error 9 message" and shut off after approximately five minutes.The external drive unit was restarted and it functioned normally.The external drive unit shut down again and was restarted three additional times prior to successful completion of the procedure.

Manufacturer Narrative

The external drive unit was returned to the company for evaluation.The investigation duplicated the reported failure on the returned drive unit.The "error code 9" was determined to be due to an inverter overload.The settings for the inverter were checked and found to be modified from the service/installation/test record.The preliminary results of the investigation reported that the change in settings could have been made by a clinician using a "booster" or removing the top of the unit and reprogramming the inverter.The investigation is ongoing.A supplemental report will be provided.

Manufacturer Narrative

On initial receipt of the reported event, the event description was reviewed and with the limited information available at that time, a decision was made to report the event.However on completion of the investigation into the reported event it can now be concluded that the incident does not meet the three basic reporting criteria referenced in 21 cfr part 803 as a marketed device did not cause or contribute to a death or serious injury, or a marketed device has not malfunctioned where the malfunction of the device or a similar marketed device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Product surveillance will continue to monitor for trends.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Corrected data: distal femur extendible implant corrected to limb salvage system.

Event Description

The jts external drive unit is used periodically to lengthen the prosthesis when the patient's limb discrepancy needs to be addressed.On (b)(6) 2012, the patient was implanted with a jts extendible distal femur implant.(compassionate use approval dated (b)(6) 2012).During a 16 mintue implant lengthening procedure performed on (b)(6) 2013, the external drive unit started flashing an "error 9 message" and shut off after approximately five minutes.The external drive unit was restarted and it functioned normally.The external drive unit shut down again and was restarted three additional times prior to successful completion of the procedure.This is a supplemental report to 3004105610-2014-00007 ((b)(4)).

• Brand Name: JTS NON-INVASIVE EXTENDIBLE DISTAL FEMUR 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 Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 4176686
• MDR Text Key: 5019849
• Report Number: 3004105610-2014-00007
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Lot Number: BME17092
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR